Human Papillomavirus Infection, Meningococcal Meningitis, Pertussis, Tetanus
Conditions
Keywords
Meningococcal, meningitis, vaccine, adolescents
Brief summary
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
Interventions
One dose of vaccine administered intramuscularly
BIOLOGICALTdap Vaccine
One dose of vaccine administered intramuscularly
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adolescents 11-18 years of age * virgins (both male and female) with no intention of becoming sexually active during the study period * who have been properly vaccinated against diphtheria, tetanus, pertussis
Exclusion criteria
* who had a previous confirmed or suspected disease caused by N. meningitidis; * who have previously been immunized with a meningococcal vaccine * who have received prior human papillomavirus (HPV) vaccine; * who have any serious acute, chronic or progressive disease * who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome; * who have a known or suspected impairment/alteration of immune function, either congenital or acquired * who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; * who have Down's syndrome or other known cytogenic disorders;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | 1 month post MenACWY vaccination | 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. |
| Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL | 1 month post Tdap vaccination | To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone |
| Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN) | 1 month post Tdap vaccination | To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups | 1 month post MenACWY vaccination | 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. |
| The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus | 1 month post Tdap vaccination | The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL. |
| Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus | 1 month post Tdap vaccination | 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. |
| Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups | 1 month post MenACWY vaccination | 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. |
| Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN | 1 month post Tdap vaccination | 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. |
| Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Days 1 to 7 | 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. |
| Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Days 1 to 7 | Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination. |
| Geometric Mean Titers (GMT) of Pertussis Antigens | 1 month post Tdap vaccination | To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone. |
| Percentage of Subjects With Anti-HPV Seroconversion | 1 month post third HPV vaccination | 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. |
| Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay | 1 month post third HPV vaccination | 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.) |
Countries
Costa Rica
Participant flow
Recruitment details
Participants were enrolled at a single center in Costa Rica.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 540 |
| 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. | 541 |
| 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. | 539 |
| Total | 1,620 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative reason | 0 | 2 | 2 |
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 30 | 28 | 34 |
| Overall Study | Protocol Violation | 5 | 7 | 4 |
| Overall Study | Unable to classify | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 29 | 30 | 42 |
Baseline characteristics
| Characteristic | MenACWY+Tdap+HPV | MenACWY→Tdap→HPV | Tdap →MenACWY → HPV | Total |
|---|---|---|---|---|
| Age, Continuous | 13.9 years STANDARD_DEVIATION 2.1 | 13.9 years STANDARD_DEVIATION 2.2 | 13.8 years STANDARD_DEVIATION 2.2 | 13.9 years STANDARD_DEVIATION 2.1 |
| Race/Ethnicity, Customized Black | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic | 539 participants | 541 participants | 539 participants | 1619 participants |
| Sex: Female, Male Female | 308 Participants | 309 Participants | 307 Participants | 924 Participants |
| Sex: Female, Male Male | 232 Participants | 232 Participants | 232 Participants | 696 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 495 / 540 | 489 / 541 | 482 / 539 |
| serious Total, serious adverse events | 1 / 540 | 7 / 541 | 3 / 539 |
Outcome results
Primary
Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone
Time frame: 1 month post Tdap vaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY→Tdap→HPV | Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN) | Anti-FHA (N=489, 457, 485) | 1106 IU/mL |
| MenACWY→Tdap→HPV | Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN) | Anti-PT (N=479, 451, 477) | 79 IU/mL |
| MenACWY→Tdap→HPV | Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN) | Anti-PRN (N=492, 458, 487) | 1563 IU/mL |
| Tdap →MenACWY → HPV | Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN) | Anti-PRN (N=492, 458, 487) | 1197 IU/mL |
| Tdap →MenACWY → HPV | Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN) | Anti-PT (N=479, 451, 477) | 63 IU/mL |
| Tdap →MenACWY → HPV | Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN) | Anti-FHA (N=489, 457, 485) | 511 IU/mL |
Comparison: Non inferiority of the immune response to Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PT antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.95% CI: [0.72, 0.9]
Comparison: Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PRN antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.95% CI: [0.58, 0.81]
Comparison: Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alon, for FHA antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.95% CI: [0.58, 0.76]
Primary
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone
Time frame: 1 month post Tdap vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY+Tdap+HPV | Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL | Diphtheria | 100 Percentage of subjects |
| MenACWY+Tdap+HPV | Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL | Tetanus | 100 Percentage of subjects |
| MenACWY→Tdap→HPV | Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL | Diphtheria | 100 Percentage of subjects |
| MenACWY→Tdap→HPV | Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL | Tetanus | 100 Percentage of subjects |
| Tdap →MenACWY → HPV | Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL | Diphtheria | 98 Percentage of subjects |
| Tdap →MenACWY → HPV | Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL | Tetanus | 100 Percentage of subjects |
Comparison: Non inferiority of the immune response to diphteria antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.95% CI: [1, 4]
Comparison: Non inferiority of the immune response to tetanus antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.95% CI: [-1, 1]
Primary
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
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.
Time frame: 1 month post MenACWY vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY+Tdap+HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup C (N=476, 472, 457) | 83 Percentage of participants |
| MenACWY+Tdap+HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup Y (N=493, 487, 460) | 83 Percentage of participants |
| MenACWY+Tdap+HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup W (N=487, 474, 458) | 77 Percentage of participants |
| MenACWY+Tdap+HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup A (N=494, 486, 458) | 80 Percentage of participants |
| MenACWY→Tdap→HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup C (N=476, 472, 457) | 84 Percentage of participants |
| MenACWY→Tdap→HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup A (N=494, 486, 458) | 82 Percentage of participants |
| MenACWY→Tdap→HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup Y (N=493, 487, 460) | 82 Percentage of participants |
| MenACWY→Tdap→HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup W (N=487, 474, 458) | 81 Percentage of participants |
| Tdap →MenACWY → HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup A (N=494, 486, 458) | 87 Percentage of participants |
| Tdap →MenACWY → HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup Y (N=493, 487, 460) | 78 Percentage of participants |
| Tdap →MenACWY → HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup W (N=487, 474, 458) | 65 Percentage of participants |
| Tdap →MenACWY → HPV | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse | Serogroup C (N=476, 472, 457) | 84 Percentage of participants |
Comparison: Immune response to Men A when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.95% CI: [-6, 3]
Comparison: Immune response to Men C when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.95% CI: [-6, 3]
Comparison: Immune response to Men W when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.95% CI: [-9, 1]
Comparison: Immune response to Men Y when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.95% CI: [-4, 5]
Comparison: Immune response to Men A when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.95% CI: [1, 10]
Comparison: Immune response to Men C when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.95% CI: [-6, 4]
Comparison: Immune response to Men W when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.95% CI: [-21, -10]
Comparison: Immune response to Men Y when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.95% CI: [-9, 1]
Secondary
Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
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.
Time frame: 1 month post MenACWY vaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY→Tdap→HPV | 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) | 81 Titers |
| MenACWY→Tdap→HPV | 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) | 67 Titers |
| MenACWY→Tdap→HPV | 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) | 159 Titers |
| MenACWY→Tdap→HPV | 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) | 70 Titers |
| Tdap →MenACWY → HPV | 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) | 57 Titers |
| Tdap →MenACWY → HPV | 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) | 68 Titers |
| Tdap →MenACWY → HPV | 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) | 104 Titers |
| Tdap →MenACWY → HPV | 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) | 95 Titers |
Secondary
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
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.
Time frame: 1 month post Tdap vaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY+Tdap+HPV | Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus | Diphtheria | 37 IU/mL |
| MenACWY+Tdap+HPV | Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus | Tetanus | 8.75 IU/mL |
| MenACWY→Tdap→HPV | Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus | Diphtheria | 10 IU/mL |
| MenACWY→Tdap→HPV | Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus | Tetanus | 12 IU/mL |
| Tdap →MenACWY → HPV | Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus | Tetanus | 10 IU/mL |
| Tdap →MenACWY → HPV | Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus | Diphtheria | 10 IU/mL |
Secondary
Geometric Mean Titers (GMT) of Pertussis Antigens
To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.
Time frame: 1 month post Tdap vaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY+Tdap+HPV | Geometric Mean Titers (GMT) of Pertussis Antigens | Anti-FHA (N=489, 457, 485) | 342 Titers |
| MenACWY+Tdap+HPV | Geometric Mean Titers (GMT) of Pertussis Antigens | Anti-PT (N=479, 451, 477) | 51 Titers |
| MenACWY+Tdap+HPV | Geometric Mean Titers (GMT) of Pertussis Antigens | Anti-PRN (N=492, 458, 487) | 819 Titers |
| MenACWY→Tdap→HPV | Geometric Mean Titers (GMT) of Pertussis Antigens | Anti-FHA (N=489, 457, 485) | 1106 Titers |
| MenACWY→Tdap→HPV | Geometric Mean Titers (GMT) of Pertussis Antigens | Anti-PT (N=479, 451, 477) | 79 Titers |
| MenACWY→Tdap→HPV | Geometric Mean Titers (GMT) of Pertussis Antigens | Anti-PRN (N=492, 458, 487) | 1563 Titers |
| Tdap →MenACWY → HPV | Geometric Mean Titers (GMT) of Pertussis Antigens | Anti-PT (N=479, 451, 477) | 63 Titers |
| Tdap →MenACWY → HPV | Geometric Mean Titers (GMT) of Pertussis Antigens | Anti-PRN (N=492, 458, 487) | 1197 Titers |
| Tdap →MenACWY → HPV | Geometric Mean Titers (GMT) of Pertussis Antigens | Anti-FHA (N=489, 457, 485) | 511 Titers |
Secondary
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
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.)
Time frame: 1 month post third HPV vaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY+Tdap+HPV | Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay | HPV 6 (N=361, 737) | 1059 Titers |
| MenACWY+Tdap+HPV | Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay | HPV 11 (N=362, 744) | 1264 Titers |
| MenACWY+Tdap+HPV | Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay | HPV 16 (N=360, 744) | 5286 Titers |
| MenACWY+Tdap+HPV | Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay | HPV 18 (N=364, 743) | 908 Titers |
| MenACWY→Tdap→HPV | Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay | HPV 18 (N=364, 743) | 1117 Titers |
| MenACWY→Tdap→HPV | Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay | HPV 6 (N=361, 737) | 1461 Titers |
| MenACWY→Tdap→HPV | Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay | HPV 16 (N=360, 744) | 6590 Titers |
| MenACWY→Tdap→HPV | Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay | HPV 11 (N=362, 744) | 1701 Titers |
Secondary
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.
Time frame: Days 1 to 7
Population: The analysis was performed on the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Malaise postvaccination 1 | 133 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Fever (≥ 38°C) postvaccination 3 | 20 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Arthralgia postvaccination 2 | 30 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Chills postvaccination 1 | 77 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Rash postvaccination 3 | 9 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Headache postvaccination 2 | 88 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site pain (N=498, 483, 468) postvac 2 | 208 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Headache postvaccination 3 | 79 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Rash postvaccination 2 | 4 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Stayed home postvaccination 1 | 110 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Arthralgia postvaccination 3 | 37 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Fever (≥ 38°C) postvaccination 2 | 17 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Nausea postvaccination 1 | 88 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Myalgia postvaccination 3 | 53 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Chills postvaccination 3 | 22 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Myalgia postvaccination 1 | 146 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Malaise postvaccination 3 | 49 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Nausea postvaccination 3 | 32 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Chills postvaccination 2 | 23 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site erythema postvaccination 3 | 60 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Arthralgia postvaccination 1 | 94 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Rash postvaccination 1 | 21 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site pain postvaccination 3 | 229 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Headache postvaccination 1 | 217 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site induration postvaccination 2 | 46 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Fever (≥ 38°C) postvaccination 1 | 27 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site pain postvaccination 1 | 265 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Nausea postvaccination 2 | 38 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site induration postvaccination 3 | 60 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site induration postvaccination 1 | 54 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Malaise postvaccination 2 | 53 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site erythema postvaccination 2 | 62 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site erythema postvaccination 1 | 74 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Myalgia postvaccination 2 | 42 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site induration postvaccination 1 | 27 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site pain postvaccination 1 | 180 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site pain (N=498, 483, 468) postvac 2 | 208 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site erythema postvaccination 2 | 48 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site erythema postvaccination 3 | 56 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site induration postvaccination 3 | 47 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Chills postvaccination 1 | 27 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Malaise postvaccination 1 | 49 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Myalgia postvaccination 1 | 32 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Arthralgia postvaccination 1 | 33 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Nausea postvaccination 2 | 30 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Malaise postvaccination 2 | 45 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Myalgia postvaccination 2 | 38 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Arthralgia postvaccination 2 | 28 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Headache postvaccination 2 | 78 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Rash postvaccination 2 | 11 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Fever (≥ 38°C) postvaccination 2 | 22 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Chills postvaccination 3 | 24 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Nausea postvaccination 3 | 35 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Malaise postvaccination 3 | 50 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Myalgia postvaccination 3 | 49 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Arthralgia postvaccination 3 | 26 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Headache postvaccination 3 | 85 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Rash postvaccination 3 | 7 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Fever (≥ 38°C) postvaccination 3 | 16 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site erythema postvaccination 1 | 36 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site induration postvaccination 2 | 37 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site pain postvaccination 3 | 227 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Nausea postvaccination 1 | 39 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Headache postvaccination 1 | 93 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Rash postvaccination 1 | 7 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Fever (≥ 38°C) postvaccination 1 | 21 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Stayed home postvaccination 1 | 26 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Chills postvaccination 2 | 22 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Rash postvaccination 3 | 10 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Myalgia postvaccination 2 | 51 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Headache postvaccination 1 | 97 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Fever (≥ 38°C) postvaccination 3 | 25 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site pain postvaccination 1 | 204 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Malaise postvaccination 2 | 34 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site erythema postvaccination 3 | 55 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site erythema postvaccination 1 | 42 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Nausea postvaccination 2 | 29 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Chills postvaccination 2 | 26 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site induration postvaccination 1 | 26 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Rash postvaccination 1 | 6 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site pain (N=498, 483, 468) postvac 2 | 189 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site induration postvaccination 2 | 50 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Arthralgia postvaccination 1 | 28 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Stayed home postvaccination 1 | 34 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site pain postvaccination 3 | 208 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Myalgia postvaccination 1 | 56 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Chills postvaccination 1 | 30 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Nausea postvaccination 3 | 34 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Chills postvaccination 3 | 25 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Malaise postvaccination 1 | 55 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Malaise postvaccination 3 | 41 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Fever (≥ 38°C) postvaccination 2 | 22 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Fever (≥ 38°C) postvaccination 1 | 23 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Myalgia postvaccination 3 | 37 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Rash postvaccination 2 | 9 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Nausea postvaccination 1 | 32 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Arthralgia postvaccination 3 | 30 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Headache postvaccination 2 | 71 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site induration postvaccination 3 | 48 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Headache postvaccination 3 | 79 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Arthralgia postvaccination 2 | 21 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination | Injection site erythema postvaccination 2 | 57 Subjects |
Secondary
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
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.
Time frame: Days 1 to 7
Population: The analysis was performed on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site pain MenACWY | 263 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site erythema MenACWY | 68 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site erythema Tdap | 78 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site induration MenACWY | 68 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site induration Tdap | 90 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Chills post-vaccination 2 | 0 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Nausea post-vaccination 1 | 88 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Myalgia post-vaccination 2 | 0 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Arthralgia post-vaccination 1 | 94 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Analgesic/Antipyretic Med. Used post-vaccination 1 | 110 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site pain Tdap | 367 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Chills post-vaccination 1 | 77 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Nausea post-vaccination 2 | 0 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Malaise post-vaccination 1 | 133 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Malaise post-vaccination 2 | 0 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Myalgia post-vaccination 1 | 146 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Arthralgia post-vaccination 2 | 0 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Headache post-vaccination 1 | 217 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Headache post-vaccination 2 | 0 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Rash post-vaccination 1 | 21 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Rash post-vaccination 2 | 0 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Fever ≥ 38°Celsius post-vaccination 1 | 27 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Fever ≥ 38°Celsius post-vaccination 2 | 0 Subjects |
| MenACWY+Tdap+HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Analgesic/Antipyretic Med. Used post-vaccination 2 | 0 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site pain MenACWY | 246 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Arthralgia post-vaccination 1 | 62 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Headache post-vaccination 2 | 125 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site erythema MenACWY | 66 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site pain Tdap | 310 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Myalgia post-vaccination 1 | 104 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site erythema Tdap | 38 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Rash post-vaccination 2 | 15 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Myalgia post-vaccination 2 | 81 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site induration MenACWY | 70 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Fever ≥ 38°Celsius post-vaccination 1 | 19 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Analgesic/Antipyretic Med. Used post-vaccination 1 | 83 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site induration Tdap | 64 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Chills post-vaccination 1 | 66 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Nausea post-vaccination 2 | 42 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Arthralgia post-vaccination 2 | 52 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Chills post-vaccination 2 | 42 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Analgesic/Antipyretic Med. Used post-vaccination 2 | 58 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Rash post-vaccination 1 | 17 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Nausea post-vaccination 1 | 72 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Headache post-vaccination 1 | 194 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Malaise post-vaccination 1 | 110 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Malaise post-vaccination 2 | 91 Subjects |
| MenACWY→Tdap→HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Fever ≥ 38°Celsius post-vaccination 2 | 25 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Myalgia post-vaccination 1 | 142 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Myalgia post-vaccination 2 | 82 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Fever ≥ 38°Celsius post-vaccination 2 | 30 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Analgesic/Antipyretic Med. Used post-vaccination 2 | 49 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site pain MenACWY | 239 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site induration Tdap | 110 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Headache post-vaccination 2 | 138 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Headache post-vaccination 1 | 200 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Fever ≥ 38°Celsius post-vaccination 1 | 17 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Nausea post-vaccination 2 | 64 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Rash post-vaccination 1 | 20 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Malaise post-vaccination 2 | 88 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site pain Tdap | 383 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Analgesic/Antipyretic Med. Used post-vaccination 1 | 96 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site erythema MenACWY | 64 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site erythema Tdap | 70 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Arthralgia post-vaccination 1 | 76 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Injection site induration MenACWY | 63 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Rash post-vaccination 2 | 13 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Chills post-vaccination 1 | 70 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Chills post-vaccination 2 | 45 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Arthralgia post-vaccination 2 | 52 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Nausea post-vaccination 1 | 82 Subjects |
| Tdap →MenACWY → HPV | Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination. | Malaise post-vaccination 1 | 115 Subjects |
Secondary
Percentage of Subjects With Anti-HPV Seroconversion
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.
Time frame: 1 month post third HPV vaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY+Tdap+HPV | Percentage of Subjects With Anti-HPV Seroconversion | HPV 6 (N=361, 737) | 99 Percentage of subjects |
| MenACWY+Tdap+HPV | Percentage of Subjects With Anti-HPV Seroconversion | HPV 11 (N=362, 744) | 100 Percentage of subjects |
| MenACWY+Tdap+HPV | Percentage of Subjects With Anti-HPV Seroconversion | HPV 16 (N=360, 744) | 100 Percentage of subjects |
| MenACWY+Tdap+HPV | Percentage of Subjects With Anti-HPV Seroconversion | HPV 18 (N=364, 743) | 100 Percentage of subjects |
| MenACWY→Tdap→HPV | Percentage of Subjects With Anti-HPV Seroconversion | HPV 18 (N=364, 743) | 99 Percentage of subjects |
| MenACWY→Tdap→HPV | Percentage of Subjects With Anti-HPV Seroconversion | HPV 6 (N=361, 737) | 100 Percentage of subjects |
| MenACWY→Tdap→HPV | Percentage of Subjects With Anti-HPV Seroconversion | HPV 16 (N=360, 744) | 100 Percentage of subjects |
| MenACWY→Tdap→HPV | Percentage of Subjects With Anti-HPV Seroconversion | HPV 11 (N=362, 744) | 100 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
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.
Time frame: 1 month post MenACWY vaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY→Tdap→HPV | 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 |
| MenACWY→Tdap→HPV | 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) | 82 Percentage of subjects |
| MenACWY→Tdap→HPV | 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) | 90 Percentage of subjects |
| MenACWY→Tdap→HPV | 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) | 99 Percentage of subjects |
| MenACWY→Tdap→HPV | 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 |
| MenACWY→Tdap→HPV | 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 |
| MenACWY→Tdap→HPV | 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) | 99 Percentage of subjects |
| MenACWY→Tdap→HPV | 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 |
| Tdap →MenACWY → HPV | 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) | 92 Percentage of subjects |
| Tdap →MenACWY → HPV | 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) | 89 Percentage of subjects |
| Tdap →MenACWY → HPV | 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) | 97 Percentage of subjects |
| Tdap →MenACWY → HPV | 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) | 95 Percentage of subjects |
| Tdap →MenACWY → HPV | 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) | 93 Percentage of subjects |
| Tdap →MenACWY → HPV | 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) | 95 Percentage of subjects |
| Tdap →MenACWY → HPV | 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) | 90 Percentage of subjects |
| Tdap →MenACWY → HPV | 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) | 94 Percentage of subjects |
Secondary
Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
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.
Time frame: 1 month post Tdap vaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY+Tdap+HPV | 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 |
| MenACWY→Tdap→HPV | Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN | Anti-PT (N=479, 451, 477) | 89 Percentages of subjects |
| MenACWY→Tdap→HPV | Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN | Anti-PRN (N=492, 458, 487) | 95 Percentages of subjects |
| MenACWY→Tdap→HPV | Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN | Anti-FHA (N=489, 457, 485) | 90 Percentages of subjects |
| Tdap →MenACWY → HPV | Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN | Anti-PRN (N=492, 458, 487) | 89 Percentages of subjects |
| Tdap →MenACWY → HPV | Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN | Anti-FHA (N=489, 457, 485) | 78 Percentages of subjects |
| Tdap →MenACWY → HPV | Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN | Anti-PT (N=479, 451, 477) | 86 Percentages of subjects |
Secondary
The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus
The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.
Time frame: 1 month post Tdap vaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY+Tdap+HPV | The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus | Diphtheria (% ≥1.0 IU/mL) | 100 Percentages of subjects |
| MenACWY+Tdap+HPV | The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus | Tetanus (% ≥1.0 IU/mL) | 100 Percentages of subjects |
| MenACWY→Tdap→HPV | The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus | Diphtheria (% ≥1.0 IU/mL) | 100 Percentages of subjects |
| MenACWY→Tdap→HPV | The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus | Tetanus (% ≥1.0 IU/mL) | 100 Percentages of subjects |
| Tdap →MenACWY → HPV | The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus | Diphtheria (% ≥1.0 IU/mL) | 98 Percentages of subjects |
| Tdap →MenACWY → HPV | The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus | Tetanus (% ≥1.0 IU/mL) | 100 Percentages of subjects |