Meningococcal Disease, Meningococcal Meningitis
Conditions
Keywords
Meningitis, healthy subject, vaccine
Brief summary
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Interventions
BIOLOGICALMeningococcal ACWY conjugate vaccine (MenACWY-CRM)
BIOLOGICALCombined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)
BIOLOGICALsaline placebo
4.5 mg sodium chloride per 0.5 ml dose
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female 11-25 years old healthy subjects; * who had received the primary immunization with a vaccine containing DT or Tdap antigens and a T, Td, or Tdap booster injection at least 5 years prior to study entry
Exclusion criteria
* previous ascertained or suspected disease caused by N. meningitidis * previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) * serious acute, chronic or progressive disease * history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component * known or suspected impairment/alteration of immune function, either congenital or acquired
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | 1 month after vaccination (Day 29) | To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of 1. the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and 2. the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | 1 month after vaccination (Day 29) | The geometric mean concentrations of antibodies ≥ 0.1 IU/mL against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens in subjects, as measured by ELISA, following concomitant administration of Tdap with MenACWY-CRM as compared to when Tdap given concomitantly with saline placebo. |
| Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | 1 month after vaccination (Day 29) | The geometric mean ratios (GMRs- day 29/day 1) of post-vaccination versus pre- vaccination antibody concentrations against diptheria, tetanus and pertussis (PT, FHA and PRN) antigens following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo. |
| Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | 1 month after vaccination (Day 29) | The percentage of subjects with serum bactericidal antibody titers(hSBA) ≥ 1:4 and ≥ 1:8 against Neisseria meningitidis serogroups A,C,W and Y,following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo. The serum bactericidal antibodies directed against N.meningitidis serogroup A, C, W and Y, are measured by human complement Serum Bactericidal Assay (hSBA). |
| The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | 1 month after vaccination (Day 29) | The hSBA geometric mean titers (GMTs) against N.meningitidis serogroups A,C,W and Y, at baseline and at one month, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine, as compared to when MenACWY-CRM was given concomitantly with saline placebo. |
| Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | 1 month after vaccination (Day 29) | The percentage of subjects with anti-diphtheria and anti-tetanus concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo. |
| Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | 1 month after vaccination (Day 29) | The percentage of subjects showing an hSBA seroresponse against N.meningitidis serogroups A,C,W and Y, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo. Seroresponse to MenACWY-CRM is defined as a pre-vaccination hSBA titer \< 1:4 to a post-vaccination hSBA titer of ≥ 1:8 or a pre-vaccination hSBA titer ≥ 1:4 to a post-vaccination titer of at least four times the baseline hSBA titer. |
| Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Day 1-7 after any vaccination | The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when MenACWY-CRM vaccine was concomitantly administered with saline placebo. |
| Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Day 1-7 after any vaccination | The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when Tdap was concomitantly administered with saline placebo |
| Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Throughout the study (Day 1 to Day 181) | The number of subjects reporting any unsolicited adverse events (AEs) when Tdap is concomitantly administered with MenACWY-CRM as compared to when MenACWY-CRM vaccine or Tdap vaccine was concomitantly administered with saline placebo. |
| Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | 1 month after vaccination (Day 29) | The geometric mean ratios (GMRs-day 29/day1)of post-vaccination versus pre- vaccination hSBA titers against N.meningitidis serogroups A,C,W and Y, when MenACWY-CRM vaccine is concomitantly administered with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo. |
Countries
Italy
Participant flow
Recruitment details
Subjects were recruited from 14 centers in Italy.
Pre-assignment details
All enrolled subjects participated in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Tdap + MenACWY-CRM Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | 361 |
| Tdap + Saline Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms | 354 |
| MenACWY-CRM + Saline Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms | 357 |
| Total | 1,072 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Unable to classify | 2 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 | 2 |
Baseline characteristics
| Characteristic | Tdap + MenACWY-CRM | Tdap + Saline | MenACWY-CRM + Saline | Total |
|---|---|---|---|---|
| Age, Continuous | 14.4 years STANDARD_DEVIATION 3.4 | 14.1 years STANDARD_DEVIATION 3.2 | 14.3 years STANDARD_DEVIATION 3.2 | 14.3 years STANDARD_DEVIATION 3.3 |
| Sex: Female, Male Female | 189 Participants | 164 Participants | 165 Participants | 518 Participants |
| Sex: Female, Male Male | 172 Participants | 190 Participants | 192 Participants | 554 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 | 297 / 359 | 309 / 353 | 238 / 357 |
| serious Total, serious adverse events | 1 / 359 | 2 / 353 | 0 / 357 |
Outcome results
Primary
Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of 1. the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and 2. the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA).
Time frame: 1 month after vaccination (Day 29)
Population: Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap+MenACWY-CRM | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (tetanus ) | 25 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (PT) 4-fold increase (N=286, 287) | 76 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (diphtheria) | 94 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (FHA)4-fold increase (N=286, 287) | 83 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (tetanus ) | 100 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (PRN) 4-fold increase (N=285, 287) | 84 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (diphtheria) | 4 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (PRN) 4-fold increase (N=285, 287) | 91 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (diphtheria) | 5 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (diphtheria) | 85 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (tetanus ) | 36 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (tetanus ) | 99 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (PT) 4-fold increase (N=286, 287) | 81 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (FHA)4-fold increase (N=286, 287) | 86 Percentages of subjects |
Comparison: Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with MenACWY-CRM as compared to Tdap given with placebo saline95% CI: [5, 14]
Comparison: Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with MenACWY-CRM compared to Tdap given concomitantly with saline placebo95% CI: [-1, 2]
Comparison: Non-inferiority of anti-PT antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo95% CI: [-12, 1]
Comparison: Non-inferiority of anti-FHA antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo95% CI: [-9, 3]
Comparison: Non-inferiority of anti-PRN antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo95% CI: [-13, -2]
Secondary
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
The geometric mean concentrations of antibodies ≥ 0.1 IU/mL against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens in subjects, as measured by ELISA, following concomitant administration of Tdap with MenACWY-CRM as compared to when Tdap given concomitantly with saline placebo.
Time frame: 1 month after vaccination (Day 29)
Population: Analysis was done on per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Tdap+MenACWY-CRM | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (PT ) (N=286,287) | 2.68 IU/mL |
| Tdap+MenACWY-CRM | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (diptheria) | 0.11 IU/mL |
| Tdap+MenACWY-CRM | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (PT) (N=286,287) | 62 IU/mL |
| Tdap+MenACWY-CRM | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (tetanus) | 0.62 IU/mL |
| Tdap+MenACWY-CRM | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (FHA) (N=286,287) | 15 IU/mL |
| Tdap+MenACWY-CRM | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (PRN) (N=285,287) | 6.45 IU/mL |
| Tdap+MenACWY-CRM | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (FHA) (N=286,287) | 186 IU/mL |
| Tdap+MenACWY-CRM | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (tetanus) | 12 IU/mL |
| Tdap+MenACWY-CRM | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (PRN) (N=285,287) | 157 IU/mL |
| Tdap+MenACWY-CRM | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (diptheria) | 7.96 IU/mL |
| Tdap+Saline | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (PRN) (N=285,287) | 254 IU/mL |
| Tdap+Saline | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (diptheria) | 0.12 IU/mL |
| Tdap+Saline | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (diptheria) | 2.77 IU/mL |
| Tdap+Saline | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (tetanus) | 0.75 IU/mL |
| Tdap+Saline | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (tetanus) | 15 IU/mL |
| Tdap+Saline | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (PT ) (N=286,287) | 2.85 IU/mL |
| Tdap+Saline | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (PT) (N=286,287) | 79 IU/mL |
| Tdap+Saline | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (FHA) (N=286,287) | 17 IU/mL |
| Tdap+Saline | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (PRN) (N=285,287) | 8.7 IU/mL |
| Tdap+Saline | Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (FHA) (N=286,287) | 219 IU/mL |
Secondary
Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
The geometric mean ratios (GMRs- day 29/day 1) of post-vaccination versus pre- vaccination antibody concentrations against diptheria, tetanus and pertussis (PT, FHA and PRN) antigens following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.
Time frame: 1 month after vaccination (Day 29)
Population: Analysis was done on per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Tdap+MenACWY-CRM | Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | tetanus | 19 Ratio |
| Tdap+MenACWY-CRM | Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | diphtheria | 72 Ratio |
| Tdap+MenACWY-CRM | Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | PT (N=286,287) | 23 Ratio |
| Tdap+MenACWY-CRM | Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | FHA (N=286,287) | 12 Ratio |
| Tdap+MenACWY-CRM | Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | PRN (N=285,287) | 24 Ratio |
| Tdap+Saline | Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | tetanus | 20 Ratio |
| Tdap+Saline | Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | PT (N=286,287) | 28 Ratio |
| Tdap+Saline | Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | PRN (N=285,287) | 29 Ratio |
| Tdap+Saline | Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | FHA (N=286,287) | 13 Ratio |
| Tdap+Saline | Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | diphtheria | 22 Ratio |
Secondary
Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
The geometric mean ratios (GMRs-day 29/day1)of post-vaccination versus pre- vaccination hSBA titers against N.meningitidis serogroups A,C,W and Y, when MenACWY-CRM vaccine is concomitantly administered with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.
Time frame: 1 month after vaccination (Day 29)
Population: Analysis was done on per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Tdap+MenACWY-CRM | Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men A | 16 Ratios |
| Tdap+MenACWY-CRM | Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men W (N=116,124) | 6.9 Ratios |
| Tdap+MenACWY-CRM | Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men C (N=118,124) | 22 Ratios |
| Tdap+MenACWY-CRM | Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men Y (N=117,125) | 14 Ratios |
| Tdap+Saline | Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men Y (N=117,125) | 14 Ratios |
| Tdap+Saline | Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men A | 23 Ratios |
| Tdap+Saline | Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men C (N=118,124) | 23 Ratios |
| Tdap+Saline | Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men W (N=116,124) | 8.09 Ratios |
Secondary
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when MenACWY-CRM vaccine was concomitantly administered with saline placebo.
Time frame: Day 1-7 after any vaccination
Population: Analysis was done on the safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site pain (Tdap or saline) site 2 | 246 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Nausea | 43 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site erythema (MenACWY) site 1 | 48 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Malaise | 65 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site erythema (Tdap or saline) site 2 | 103 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site pain (MenACWY) site 1 | 82 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Arthralgia | 57 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site induration (Tdap or saline) site 2 | 118 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Headache | 129 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site induration (MenACWY) site 1 | 41 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Fever ≥ 38°C | 11 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Systemic | 198 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Other | 42 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Local | 278 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Stayed home due to reaction (N=358,357) | 12 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Chills | 39 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Analgesic Antipyretic medication used | 38 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Myalgia | 118 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Analgesic Antipyretic medication used | 31 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Local | 179 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site pain (MenACWY) site 1 | 116 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site erythema (MenACWY) site 1 | 66 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site induration (MenACWY) site 1 | 59 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site pain (Tdap or saline) site 2 | 57 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site erythema (Tdap or saline) site 2 | 37 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Injection site induration (Tdap or saline) site 2 | 23 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Systemic | 171 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Chills | 47 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Nausea | 28 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Malaise | 43 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Myalgia | 79 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Arthralgia | 40 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Headache | 128 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Fever ≥ 38°C | 14 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Other | 33 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo | Stayed home due to reaction (N=358,357) | 12 Participants |
Secondary
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when Tdap was concomitantly administered with saline placebo
Time frame: Day 1-7 after any vaccination
Population: Analysis was done on the safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Local | 278 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site pain (Tdap) site 2 | 227 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site erythema (Tdap) site 2 | 103 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site induration (Tdap) site 2 | 110 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site pain (MenACWY or saline) site 1 | 82 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site erythema (MenACWY or saline) site 1 | 48 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site induration(MenACWY or saline)site1 | 41 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Systemic | 198 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Chills | 39 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Nausea | 43 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Malaise | 65 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Myalgia | 118 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Arthralgia | 57 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Headache | 129 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Fever ≥ 38°C | 11 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Other | 42 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Stayed home due to reaction (N=358,353) | 12 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Analgesic Antipyretic medication used | 38 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Headache | 110 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Local | 282 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Nausea | 35 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site pain (Tdap) site 2 | 246 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Analgesic Antipyretic medication used | 38 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site erythema (Tdap) site 2 | 103 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Malaise | 57 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site induration (Tdap) site 2 | 118 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Fever ≥ 38°C | 7 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site pain (MenACWY or saline) site 1 | 41 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Myalgia | 127 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site erythema (MenACWY or saline) site 1 | 34 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Stayed home due to reaction (N=358,353) | 15 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Injection site induration(MenACWY or saline)site1 | 27 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Arthralgia | 60 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Systemic | 202 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Other | 39 Participants |
| Tdap+Saline | Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo | Chills | 41 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
The number of subjects reporting any unsolicited adverse events (AEs) when Tdap is concomitantly administered with MenACWY-CRM as compared to when MenACWY-CRM vaccine or Tdap vaccine was concomitantly administered with saline placebo.
Time frame: Throughout the study (Day 1 to Day 181)
Population: This analysis was done on the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Any AE (Day 1 to 29) | 43 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related AE (Day 1 to 29) | 8 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Serious AEs (Day 1 to 29) | 0 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | AE's leading to discontinuation (Day 1 to 29) | 0 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related SAE(Day 1 to 29) | 0 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Death ( Day 1 to 29) | 0 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Any AE (Day 30 to 181) | 42 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related AE (Day 30 to 181) | 0 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Serious AEs (Day 30 to 181) | 1 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | AE's leading to discontinuation (Day 30 to 181) | 0 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related SAE (Day 30 to 181) | 0 Participants |
| Tdap+MenACWY-CRM | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Death (Day 30 to 181) | 0 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Death (Day 30 to 181) | 0 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Any AE (Day 1 to 29) | 31 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Any AE (Day 30 to 181) | 36 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Serious AEs (Day 30 to 181) | 2 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related AE (Day 1 to 29) | 6 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Death ( Day 1 to 29) | 0 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related SAE (Day 30 to 181) | 0 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Serious AEs (Day 1 to 29) | 0 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related AE (Day 30 to 181) | 0 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related SAE(Day 1 to 29) | 0 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | AE's leading to discontinuation (Day 1 to 29) | 0 Participants |
| Tdap+Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | AE's leading to discontinuation (Day 30 to 181) | 0 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | AE's leading to discontinuation (Day 1 to 29) | 0 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related SAE(Day 1 to 29) | 0 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | AE's leading to discontinuation (Day 30 to 181) | 0 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Death ( Day 1 to 29) | 0 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Any AE (Day 30 to 181) | 39 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related AE (Day 30 to 181) | 0 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related SAE (Day 30 to 181) | 0 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Any AE (Day 1 to 29) | 48 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Possibly/probably related AE (Day 1 to 29) | 6 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Serious AEs (Day 30 to 181) | 0 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Serious AEs (Day 1 to 29) | 0 Participants |
| MenACWY-CRM + Saline | Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo | Death (Day 30 to 181) | 0 Participants |
Secondary
Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
The percentage of subjects with anti-diphtheria and anti-tetanus concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.
Time frame: 1 month after vaccination (Day 29)
Population: Analysis was done on per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap+MenACWY-CRM | Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (diphtheria) | 55 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (diphtheria) | 100 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (tetanus) | 97 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (tetanus) | 100 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (tetanus) | 100 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (diphtheria) | 63 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | Day 1 (tetanus) | 97 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo | Day 29 (diphtheria) | 100 Percentages of subjects |
Secondary
Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
The percentage of subjects showing an hSBA seroresponse against N.meningitidis serogroups A,C,W and Y, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo. Seroresponse to MenACWY-CRM is defined as a pre-vaccination hSBA titer \< 1:4 to a post-vaccination hSBA titer of ≥ 1:8 or a pre-vaccination hSBA titer ≥ 1:4 to a post-vaccination titer of at least four times the baseline hSBA titer.
Time frame: 1 month after vaccination (Day 29)
Population: Analysis was done on per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap+MenACWY-CRM | Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men A | 74 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men W (N=116, 124) | 58 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men C (N=118, 124) | 82 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men Y (N=117, 125) | 70 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men C (N=118, 124) | 78 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men A | 80 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men Y (N=117, 125) | 70 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Men W (N=116, 124) | 59 Percentages of subjects |
Secondary
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
The percentage of subjects with serum bactericidal antibody titers(hSBA) ≥ 1:4 and ≥ 1:8 against Neisseria meningitidis serogroups A,C,W and Y,following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo. The serum bactericidal antibodies directed against N.meningitidis serogroup A, C, W and Y, are measured by human complement Serum Bactericidal Assay (hSBA).
Time frame: 1 month after vaccination (Day 29)
Population: Analysis was done on per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men C) hSBA ≥ 1:8 (N=118,124) | 25 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men Y) hSBA ≥ 1:8 (N=117,125) | 38 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men C) hSBA ≥ 1:4 (N=118,124) | 94 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men W) hSBA ≥ 1:8 (N=116,124) | 53 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men W) hSBA ≥ 1:4 (N=116,124) | 57 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men Y) hSBA ≥ 1:8 (N=117,125) | 93 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men W) hSBA ≥ 1:4 (N=116,124) | 97 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men C) hSBA ≥ 1:8 (N=118,124) | 92 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men Y) hSBA ≥ 1:4 (N=117,125) | 47 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men A) hSBA ≥ 1:4 | 3 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men Y) hSBA ≥ 1:4 (N=117,125) | 96 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men W) hSBA ≥ 1:8 (N=116,124) | 96 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men A) hSBA ≥ 1:8 | 2 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men A) hSBA ≥ 1:4 | 79 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men A) hSBA ≥ 1:8 | 74 Percentages of subjects |
| Tdap+MenACWY-CRM | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men C) hSBA ≥ 1:4 (N=118,124) | 36 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men A) hSBA ≥ 1:8 | 80 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men C) hSBA ≥ 1:8 (N=118,124) | 25 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men C) hSBA ≥ 1:8 (N=118,124) | 88 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men W) hSBA ≥ 1:8 (N=116,124) | 56 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men W) hSBA ≥ 1:8 (N=116,124) | 97 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men Y) hSBA ≥ 1:8 (N=117,125) | 38 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men Y) hSBA ≥ 1:8 (N=117,125) | 94 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men A) hSBA ≥ 1:4 | 5 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men A) hSBA ≥ 1:4 | 83 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men C) hSBA ≥ 1:4 (N=118,124) | 30 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men C) hSBA ≥ 1:4 (N=118,124) | 90 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men W) hSBA ≥ 1:4 (N=116,124) | 56 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men W) hSBA ≥ 1:4 (N=116,124) | 97 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men Y) hSBA ≥ 1:4 (N=117,125) | 42 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men Y) hSBA ≥ 1:4 (N=117,125) | 97 Percentages of subjects |
| Tdap+Saline | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men A) hSBA ≥ 1:8 | 4 Percentages of subjects |
Secondary
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
The hSBA geometric mean titers (GMTs) against N.meningitidis serogroups A,C,W and Y, at baseline and at one month, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine, as compared to when MenACWY-CRM was given concomitantly with saline placebo.
Time frame: 1 month after vaccination (Day 29)
Population: Analysis was done on per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Tdap+MenACWY-CRM | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men A) | 2.14 Titers |
| Tdap+MenACWY-CRM | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men A) | 34 Titers |
| Tdap+MenACWY-CRM | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men C) N=118,124 | 4 Titers |
| Tdap+MenACWY-CRM | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men C) N=118,124 | 89 Titers |
| Tdap+MenACWY-CRM | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men W) N=116,124 | 11 Titers |
| Tdap+MenACWY-CRM | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men W) N=116,124 | 73 Titers |
| Tdap+MenACWY-CRM | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men Y) N=117,125 | 5.38 Titers |
| Tdap+MenACWY-CRM | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men Y) N=117,125 | 73 Titers |
| Tdap+Saline | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men Y) N=117,125 | 70 Titers |
| Tdap+Saline | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men A) | 2.21 Titers |
| Tdap+Saline | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men W) N=116,124 | 9.49 Titers |
| Tdap+Saline | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men A) | 50 Titers |
| Tdap+Saline | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men Y) N=117,125 | 5 Titers |
| Tdap+Saline | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 1 (Men C) N=118,124 | 3.92 Titers |
| Tdap+Saline | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men W) N=116,124 | 77 Titers |
| Tdap+Saline | The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo | Day 29 (Men C) N=118,124 | 92 Titers |