Meningococcal Vaccines, Vaccines
Conditions
Keywords
vaccine, rLP2086, MCV4, Tdap, meningitis B, N. meningitidis serogroup B, adolescents, observer-blind
Brief summary
This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.
Interventions
BIOLOGICALrLP2086 + MCV4 + Tdap
At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.
BIOLOGICALMCV4 + Tdap + saline
At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only.
BIOLOGICALrLP2086 + saline
At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6).
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study. * Parent /legally authorized representative and subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures. * Male or female subject aged greater than or equal to 10 and \<13 years at the time of enrollment. * Available for the entire study period and can be reached by telephone. * Healthy subject as determined by medical history, physical examination, and judgment of the investigator. * Has received full series (5-dose series is preferred, 4-dose catch up series is allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per country specific recommendations applicable at the time of receipt. * Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study.
Exclusion criteria
* Previous vaccination with any meningococcal serogroup B vaccine. * Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the first study vaccination. * Previous vaccination with any MCV4 vaccine. * A previous anaphylactic reaction to any vaccine or vaccine-related component. * Contraindication to vaccination with MCV4 and/or Tdap vaccine. * Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. * Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. * A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may not be included. * History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea. * Significant neurological disorder or history of seizure (excluding simple febrile seizure). * Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination. * Current chronic use of systemic antibiotics. * Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3 | 1 Month after Vaccination 3 | Antibody hSBA GMTs of primary strain PMB80 \[A22\] and PMB2948 \[B24\] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively. |
| Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens | 1 Month after Vaccination 1 | Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs. |
| Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens | 1 Month after Vaccination 1 | Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs. |
| Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens | 1 Month after Vaccination 1 | Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3 | Antibody hSBA of primary strain PMB80 \[A22\] and PMB2948 \[B24\] with hSBA titers \>=1:4, \>=1:8, \>=1:16, \>=1:32, \>=1:64, and \>=1:128 were computed along with corresponding 2-sided 95% CIs. |
| Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3 | Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 \[A22\] and 1:8 for PMB2948 \[B24\]. |
| Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | 1 Month after Vaccination 1 | Seroconversion rate for Tdap antigens was defined as greater than or equal to (\>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (\<=), greater than (\>) cutoff value, respectively. For MCV4 antigens \>=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value \>= lower limit of quantitation (LLOQ), postdose rSBA titers \>=2×LLOQ if baseline value was less than (\<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively. |
| Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens | 1 Month after Vaccination 1 | Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs. |
| Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 | Before Vaccination 1, 1 Month after Vaccination (Vac) 2 | Antibody hSBA of primary strain PMB80 \[A22\] and PMB2948 \[B24\] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immunogloblulin G (IgG) Measured by GMC | Before Vaccination 1, 1 Month after Vaccination 1 | IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers. |
| Percentage of Participants With at Least One Adverse Event (AE) | Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. |
| Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | 1 Month after Vaccination (Vac) 2, 3 | — |
Countries
United States
Participant flow
Pre-assignment details
A total of 2648 participants were enrolled in this study. Of these, 19 participants were randomized but did not receive study vaccination.
Participants by arm
| Arm | Count |
|---|---|
| MCV4+Tdap+rLP2086 Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. | 888 |
| MCV4+Tdap+Saline Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. | 878 |
| Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month. | 882 |
| Total | 2,648 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 12 | 5 | 6 |
| Overall Study | Lost to Follow-up | 52 | 53 | 51 |
| Overall Study | Medication error | 7 | 5 | 6 |
| Overall Study | No longer meets eligibility criteria | 18 | 9 | 19 |
| Overall Study | No longer willing to participate | 52 | 38 | 54 |
| Overall Study | Other | 9 | 8 | 6 |
| Overall Study | Protocol Violation | 12 | 19 | 16 |
| Overall Study | Randomized but not vaccinated | 4 | 8 | 7 |
Baseline characteristics
| Characteristic | MCV4+Tdap+rLP2086 | MCV4+Tdap+Saline | Saline+Saline+rLP2086 | Total |
|---|---|---|---|---|
| Age, Continuous | 10.6 Years STANDARD_DEVIATION 0.7 | 10.6 Years STANDARD_DEVIATION 0.69 | 10.6 Years STANDARD_DEVIATION 0.67 | 10.6 Years STANDARD_DEVIATION 0.69 |
| Sex: Female, Male Female | 454 Participants | 427 Participants | 417 Participants | 1298 Participants |
| Sex: Female, Male Male | 434 Participants | 451 Participants | 465 Participants | 1350 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 | 277 / 883 | 260 / 870 | 292 / 875 |
| serious Total, serious adverse events | 15 / 883 | 9 / 870 | 11 / 875 |
Outcome results
Primary
Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens
Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.
Time frame: 1 Month after Vaccination 1
Population: Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens | Pertussis toxoid | 13.2 EU/mL |
| MCV4+Tdap+rLP2086 | Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens | Pertussis filamentous hemagglutinin | 112.0 EU/mL |
| MCV4+Tdap+rLP2086 | Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens | Pertussis pertactin | 202.0 EU/mL |
| MCV4+Tdap+rLP2086 | Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens | Pertussis fimbrial agglutinogens types 2+3 | 138.1 EU/mL |
| MCV4+Tdap+Saline | Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens | Pertussis fimbrial agglutinogens types 2+3 | 154.2 EU/mL |
| MCV4+Tdap+Saline | Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens | Pertussis toxoid | 14.2 EU/mL |
| MCV4+Tdap+Saline | Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens | Pertussis pertactin | 228.9 EU/mL |
| MCV4+Tdap+Saline | Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens | Pertussis filamentous hemagglutinin | 122.9 EU/mL |
Comparison: Pertussis filamentous hemagglutinin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis filamentous hemagglutinin antigens).95% CI: [0.84, 0.98]
Comparison: Pertussis pertactin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis pertactin antigens).95% CI: [0.8, 0.98]
Comparison: Pertussis fimbriae agglutinogens types 2 + 3: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis fimbriae agglutinogens types 2 + 3 antigens).95% CI: [0.74, 1.08]
Comparison: Pertussis toxoid: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Pertussis toxoid).95% CI: [0.85, 1.02]
Primary
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens
Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.
Time frame: 1 Month after Vaccination 1
Population: Post vaccination 1 evaluable immunogenicity population: eligible participants randomized to Group 1 or 2, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens | Diphtheria | 9.3 IU/mL |
| MCV4+Tdap+rLP2086 | Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens | Tetanus | 9.4 IU/mL |
| MCV4+Tdap+Saline | Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens | Diphtheria | 9.8 IU/mL |
| MCV4+Tdap+Saline | Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens | Tetanus | 10.3 IU/mL |
Comparison: Diphtheria: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Diphtheria antigens).95% CI: [0.86, 1.03]
Comparison: Tetanus: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Tetanus antigens).95% CI: [0.85, 0.99]
Primary
Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens
Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.
Time frame: 1 Month after Vaccination 1
Population: Post vaccination 1 evaluable immunogenicity population. Here, 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup C (N=768, 767) | 1679.2 titer |
| MCV4+Tdap+rLP2086 | Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup W-135 (N=751, 765) | 5925.1 titer |
| MCV4+Tdap+rLP2086 | Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup Y (N=771, 770) | 2212.6 titer |
| MCV4+Tdap+rLP2086 | Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup A (N=763, 772) | 4647.3 titer |
| MCV4+Tdap+Saline | Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup Y (N=771, 770) | 2244.9 titer |
| MCV4+Tdap+Saline | Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup C (N=768, 767) | 1650.2 titer |
| MCV4+Tdap+Saline | Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup A (N=763, 772) | 5113.0 titer |
| MCV4+Tdap+Saline | Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup W-135 (N=751, 765) | 6367.9 titer |
Comparison: Serogroup A: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup A antigens).95% CI: [0.82, 1.01]
Comparison: Serogroup C: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup C antigens).95% CI: [0.9, 1.15]
Comparison: Serogroup Y: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup Y antigens).95% CI: [0.89, 1.09]
Comparison: Serogroup W-135: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup W-135 antigens).95% CI: [0.83, 1.04]
Primary
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3
Antibody hSBA GMTs of primary strain PMB80 \[A22\] and PMB2948 \[B24\] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
Time frame: 1 Month after Vaccination 3
Population: Post vaccination 3 evaluable immunogenicity population: eligible participants randomized to Group 1 or 3, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3 | PMB80 [A22] (N=679, 674) | 45.9 titer |
| MCV4+Tdap+rLP2086 | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3 | PMB2948 [B24] (N=670, 656) | 24.8 titer |
| MCV4+Tdap+Saline | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3 | PMB80 [A22] (N=679, 674) | 49.7 titer |
| MCV4+Tdap+Saline | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3 | PMB2948 [B24] (N=670, 656) | 27.4 titer |
Comparison: PMB80 \[A22\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).95% CI: [0.84, 1.02]
Comparison: PMB2948 \[B24\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).95% CI: [0.82, 1]
Secondary
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens
Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.
Time frame: 1 Month after Vaccination 1
Population: Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid, determinate assay results for given antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens | Tetanus | 99.1 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens | Diphtheria | 98.1 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens | Tetanus | 99.0 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens | Diphtheria | 99.0 percentage of participants |
Secondary
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens
Seroconversion rate for Tdap antigens was defined as greater than or equal to (\>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (\<=), greater than (\>) cutoff value, respectively. For MCV4 antigens \>=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value \>= lower limit of quantitation (LLOQ), postdose rSBA titers \>=2×LLOQ if baseline value was less than (\<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.
Time frame: 1 Month after Vaccination 1
Population: Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid, determinate assay results for given antigen at specified time point and baseline. 'N' signifies number of participants with seroresponse.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Diphtheria (N=774, 780) | 98.6 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Tetanus (N=774, 780) | 97.7 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Pertussis toxoid (N=774, 780) | 68.1 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Pertussis filamentous hemagglutinin (N=774, 780) | 85.3 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Pertussis pertactin (N=774, 780) | 96.0 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Pertussis fimbriae AG types 2+3 (N=774, 780) | 79.5 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup A (N=712, 736) | 85.4 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup C (N=738, 742) | 89.3 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup Y (N=754, 753) | 90.5 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup W-135 (N=729, 752) | 97.1 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup C (N=738, 742) | 88.9 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Diphtheria (N=774, 780) | 98.3 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Pertussis fimbriae AG types 2+3 (N=774, 780) | 81.9 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Tetanus (N=774, 780) | 97.4 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup W-135 (N=729, 752) | 97.2 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Pertussis toxoid (N=774, 780) | 72.7 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup A (N=712, 736) | 88.6 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Pertussis filamentous hemagglutinin (N=774, 780) | 89.2 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Serogroup Y (N=754, 753) | 93.6 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens | Pertussis pertactin (N=774, 780) | 96.2 percentage of participants |
Secondary
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)
Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 \[A22\] and 1:8 for PMB2948 \[B24\].
Time frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3
Population: Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | Before Vaccination 1: PMB80[A22] 1:16 (N=677, 677) | 4.4 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | 1 month after Vac 2: PMB80[A22] 1:16 (N= 669, 665) | 68.0 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | 1 month after Vac 3: PMB80 [A22] 1:16 (N=679, 674) | 87.5 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | Before Vaccination 1: PMB2948[B24] 1:8 (N=677,676) | 1.6 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | 1 month after Vac 2: PMB2948[B24] 1:8 (N=656, 650) | 62.3 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | 1 month after Vac 3: PMB2948[B24] 1:8 (N=670, 656) | 90.0 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | 1 month after Vac 2: PMB2948[B24] 1:8 (N=656, 650) | 66.0 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | Before Vaccination 1: PMB80[A22] 1:16 (N=677, 677) | 5.6 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | Before Vaccination 1: PMB2948[B24] 1:8 (N=677,676) | 3.4 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | 1 month after Vac 2: PMB80[A22] 1:16 (N= 669, 665) | 68.0 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | 1 month after Vac 3: PMB2948[B24] 1:8 (N=670, 656) | 92.7 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) | 1 month after Vac 3: PMB80 [A22] 1:16 (N=679, 674) | 91.4 percentage of participants |
Secondary
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Antibody hSBA of primary strain PMB80 \[A22\] and PMB2948 \[B24\] with hSBA titers \>=1:4, \>=1:8, \>=1:16, \>=1:32, \>=1:64, and \>=1:128 were computed along with corresponding 2-sided 95% CIs.
Time frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3
Population: Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB2948[B24] 1:4 (N=677,676) | 2.1 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB80[A22] 1:32 (N=679, 674) | 81.3 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB2948[B24] 1:4 (N=656, 650) | 64.8 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB80[A22] 1:4 (N=669, 665) | 68.2 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB2948[B24] 1:4 (N=670, 656) | 90.7 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB80[A22] 1:64 (N=677,677) | 0.7 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB2948[B24] 1:16(N=677,676) | 1.5 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB80[A22] 1:8 (N=679, 674) | 87.6 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB2948[B24] 1:16(N=656,650) | 57.6 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB80[A22] 1:64 (N= 669, 665) | 25.6 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB2948[B24] 1:16(N=670,656) | 86.7 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB80[A22] 1:8 (N=677, 677) | 5.0 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB2948[B24] 1:32(N=677,676) | 0.4 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB80[A22] 1:64 (N=679, 674) | 52.7 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB2948[B24] 1:32(N=656,650) | 26.2 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB80[A22] 1:32 (N=677, 677) | 2.7 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB2948[B24] 1:32(N=670, 656) | 55.1 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB80[A22] 1:128 (N=677,677) | 0.1 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1:PMB2948[B24] 1:64(N= 677,676) | 0.4 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB80[A22] 1:4 (N=679, 674) | 87.8 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB2948[B24] 1:64 (N=656,650) | 8.7 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB80[A22] 1:128 (N=669, 665) | 6.9 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB2948[B24] 1:64 (N=670,656) | 22.5 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB80[A22] 1:32 (N=669, 665) | 55.0 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1:PMB2948[B24] 1:128(N=677,676) | 0.1 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB80[A22] 1:128 (N=679, 674) | 23.6 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB2948[B24] 1:128(N=656,650) | 2.4 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB80[A22] 1:8 (N=669, 665) | 68.2 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB2948[B24] 1:128(N=670,656) | 6.6 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB80[A22] 1:4 (N=677,677) | 6.9 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB2948[B24] 1:128(N=670,656) | 7.8 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB80[A22] 1:4 (N=677,677) | 7.5 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB80[A22] 1:4 (N=669, 665) | 68.6 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB80[A22] 1:4 (N=679, 674) | 91.7 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB80[A22] 1:8 (N=677, 677) | 6.4 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB80[A22] 1:8 (N=669, 665) | 68.1 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB80[A22] 1:8 (N=679, 674) | 91.5 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB80[A22] 1:32 (N=677, 677) | 3.2 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB80[A22] 1:32 (N=669, 665) | 54.4 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB80[A22] 1:32 (N=679, 674) | 84.7 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB80[A22] 1:64 (N=677,677) | 1.0 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB80[A22] 1:64 (N= 669, 665) | 25.0 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB80[A22] 1:64 (N=679, 674) | 55.6 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB80[A22] 1:128 (N=677,677) | 0.4 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB80[A22] 1:128 (N=669, 665) | 7.5 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB80[A22] 1:128 (N=679, 674) | 23.3 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB2948[B24] 1:4 (N=677,676) | 3.7 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB2948[B24] 1:4 (N=656, 650) | 68.2 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB2948[B24] 1:4 (N=670, 656) | 93.1 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB2948[B24] 1:16(N=677,676) | 2.1 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB2948[B24] 1:16(N=656,650) | 60.3 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB2948[B24] 1:16(N=670,656) | 88.9 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1: PMB2948[B24] 1:32(N=677,676) | 0.6 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB2948[B24] 1:32(N=656,650) | 28.2 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB2948[B24] 1:32(N=670, 656) | 60.7 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1:PMB2948[B24] 1:64(N= 677,676) | 0.3 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB2948[B24] 1:64 (N=656,650) | 10.3 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 3: PMB2948[B24] 1:64 (N=670,656) | 24.1 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | Before Vaccination 1:PMB2948[B24] 1:128(N=677,676) | 0.1 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level | 1 month after Vac 2: PMB2948[B24] 1:128(N=656,650) | 3.4 percentage of participants |
Secondary
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2
Antibody hSBA of primary strain PMB80 \[A22\] and PMB2948 \[B24\] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.
Time frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2
Population: Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 | Before Vaccination 1: PMB80 [A22] (N=677, 677) | 8.5 titer |
| MCV4+Tdap+rLP2086 | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 | Before Vaccination 1: PMB2948 [B24] (N=677, 676) | 4.1 titer |
| MCV4+Tdap+rLP2086 | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 | 1 Month after Vac 2: PMB80 [A22] (N=669, 665) | 23.7 titer |
| MCV4+Tdap+rLP2086 | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 | 1 Month after Vac 2: PMB2948 [B24] (N=656, 650) | 12.0 titer |
| MCV4+Tdap+Saline | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 | 1 Month after Vac 2: PMB2948 [B24] (N=656, 650) | 13.0 titer |
| MCV4+Tdap+Saline | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 | Before Vaccination 1: PMB80 [A22] (N=677, 677) | 8.6 titer |
| MCV4+Tdap+Saline | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 | 1 Month after Vac 2: PMB80 [A22] (N=669, 665) | 23.8 titer |
| MCV4+Tdap+Saline | Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 | Before Vaccination 1: PMB2948 [B24] (N=677, 676) | 4.2 titer |
Other Pre-specified
Immunogloblulin G (IgG) Measured by GMC
IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.
Time frame: Before Vaccination 1, 1 Month after Vaccination 1
Population: Post vaccination 1 evaluable immunogenicity population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Immunogloblulin G (IgG) Measured by GMC | Before Vaccination 1: Serogroup A | 0.17 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+rLP2086 | Immunogloblulin G (IgG) Measured by GMC | 1 Month after Vaccination 1: Serogroup A | 11.42 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+rLP2086 | Immunogloblulin G (IgG) Measured by GMC | Before Vaccination 1: Serogroup C | 0.11 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+rLP2086 | Immunogloblulin G (IgG) Measured by GMC | 1 Month after Vaccination 1: Serogroup C | 5.59 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+rLP2086 | Immunogloblulin G (IgG) Measured by GMC | Before Vaccination 1: Serogroup Y | 0.14 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+rLP2086 | Immunogloblulin G (IgG) Measured by GMC | 1 Month after Vaccination 1: Serogroup Y | 2.49 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+rLP2086 | Immunogloblulin G (IgG) Measured by GMC | Before Vaccination 1: Serogroup W-135 | 0.13 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+rLP2086 | Immunogloblulin G (IgG) Measured by GMC | 1 Month after Vaccination 1: Serogroup W-135 | 1.79 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+Saline | Immunogloblulin G (IgG) Measured by GMC | 1 Month after Vaccination 1: Serogroup W-135 | 1.84 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+Saline | Immunogloblulin G (IgG) Measured by GMC | Before Vaccination 1: Serogroup A | 0.15 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+Saline | Immunogloblulin G (IgG) Measured by GMC | Before Vaccination 1: Serogroup Y | 0.13 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+Saline | Immunogloblulin G (IgG) Measured by GMC | 1 Month after Vaccination 1: Serogroup A | 11.38 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+Saline | Immunogloblulin G (IgG) Measured by GMC | Before Vaccination 1: Serogroup W-135 | 0.13 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+Saline | Immunogloblulin G (IgG) Measured by GMC | Before Vaccination 1: Serogroup C | 0.11 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+Saline | Immunogloblulin G (IgG) Measured by GMC | 1 Month after Vaccination 1: Serogroup Y | 2.14 microgram per milliliter (mcg/mL) |
| MCV4+Tdap+Saline | Immunogloblulin G (IgG) Measured by GMC | 1 Month after Vaccination 1: Serogroup C | 5.47 microgram per milliliter (mcg/mL) |
Other Pre-specified
Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level
Time frame: 1 Month after Vaccination (Vac) 2, 3
Population: Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point and baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | 1 month after Vac 2 : PMB80 [A22] (N=663, 663) | 64.3 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | 1 month after Vac 3 : PMB80 [A22] (N=673, 672) | 84.0 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | 1 month after Vac 2 : PMB2948 [B24] (N=650, 647) | 56.3 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | 1 month after Vac 3 : PMB2948 [B24] (N=664, 653) | 85.7 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | 1 month after Vac 3 : PMB2948 [B24] (N=664, 653) | 87.7 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | 1 month after Vac 2 : PMB80 [A22] (N=663, 663) | 63.7 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | 1 month after Vac 2 : PMB2948 [B24] (N=650, 647) | 58.4 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | 1 month after Vac 3 : PMB80 [A22] (N=673, 672) | 88.7 percentage of participants |
Other Pre-specified
Percentage of Participants With at Least One Adverse Event (AE)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Time frame: Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3)
Population: Safety population included all participants who received at least 1 dose of the investigational product and had safety information available. 'N' signifies participants evaluable for this measure during specified time period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MCV4+Tdap+rLP2086 | Percentage of Participants With at Least One Adverse Event (AE) | Follow-up phase: Adverse Events (N=777,776,771) | 1.0 percentage of participants |
| MCV4+Tdap+rLP2086 | Percentage of Participants With at Least One Adverse Event (AE) | Vaccination phase: Adverse Events (N=883,870,875) | 42.9 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With at Least One Adverse Event (AE) | Follow-up phase: Adverse Events (N=777,776,771) | 0.5 percentage of participants |
| MCV4+Tdap+Saline | Percentage of Participants With at Least One Adverse Event (AE) | Vaccination phase: Adverse Events (N=883,870,875) | 42.6 percentage of participants |
| Saline+Saline+rLP2086 | Percentage of Participants With at Least One Adverse Event (AE) | Vaccination phase: Adverse Events (N=883,870,875) | 46.2 percentage of participants |
| Saline+Saline+rLP2086 | Percentage of Participants With at Least One Adverse Event (AE) | Follow-up phase: Adverse Events (N=777,776,771) | 1.3 percentage of participants |