| 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
- the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and
- 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).
| 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 | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | 1 month after vaccination (Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tdap+MenACWY-CRM | Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | | OG001 | Tdap+Saline | Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms |
| | | Title | Denominators | Categories |
|---|
| Day 1 (diphtheria) | | | Title | Measurements |
|---|
| - OG0004(2 to 7)
- OG0015(3 to 7)
|
| | Day 29 (diphtheria) | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with MenACWY-CRM as compared to Tdap given with placebo saline | | | | | Vaccine Group difference | 9 | | | 2-Sided | 95 | 5 | 14 | | | | Yes | Non-Inferiority or Equivalence | The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus(Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination |
|
| 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. | Analysis was done on per-protocol population. | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | 1 month after vaccination (Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tdap+MenACWY-CRM | Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | | OG001 | Tdap+Saline | Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms |
| |
| 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. | Analysis was done on per-protocol population. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | 1 month after vaccination (Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tdap+ MenACWY-CRM | Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | | OG001 | Tdap+Saline | Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms |
| |
| 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. | Analysis was done on per-protocol population. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | 1 month after vaccination (Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tdap+ MenACWY-CRM | Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | | OG001 | Tdap+Saline | Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms |
| |
| 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). | Analysis was done on per-protocol population. | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | 1 month after vaccination (Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tdap + MenACWY-CRM | Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | | OG001 | MenACWY-CRM + Saline | Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms |
| |
| 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. | Analysis was done on per-protocol population. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 month after vaccination (Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tdap + MenACWY-CRM | Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | | OG001 | MenACWY-CRM + Saline | Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms |
| |
| 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. | Analysis was done on per-protocol population. | Posted | | Geometric Mean | 95% Confidence Interval | Ratios | | 1 month after vaccination (Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tdap + MenACWY-CRM | Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | | OG001 | MenACWY-CRM + Saline | Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms |
| |
| 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. | Analysis was done on per-protocol population. | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | 1 month after vaccination (Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tdap + MenACWY-CRM | Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | | OG001 | MenACWY-CRM + Saline | Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms |
| |
| 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. | Analysis was done on the safety population | Posted | | Number | | Participants | | Day 1-7 after any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Tdap + MenACWY-CRM | Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | | OG001 | MenACWY-CRM + Saline | Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms |
| |
| 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 | Analysis was done on the safety population | Posted | | Number | | Participants | | Day 1-7 after any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Tdap + MenACWY-CRM | Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | | OG001 | Tdap + Saline | Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms |
| |
| 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. | This analysis was done on the safety population. | Posted | | Number | | Participants | | Throughout the study (Day 1 to Day 181) | | | | ID | Title | Description |
|---|
| OG000 | Tdap + MenACWY-CRM | Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms | | OG001 | Tdap + Saline | Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms | | OG002 | MenACWY-CRM + Saline | Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms |
| |