Pertussis
Conditions
Brief summary
The purpose of this study is to evaluate the persistence of immune response against the three pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study vaccines or Boostrix® during V113\_01 study. There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood was withdrawn. No vaccine was administered and no safety data was collected in this study.
Interventions
BIOLOGICALaP booster
Acellular pertussis vaccine: Acellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm. Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) To ensure all subjects receive a tetanus and diphtheria booster vaccination, an injection was administered on Study Day 30, one month after the administration of the investigational vaccine.
BIOLOGICALTdaP booster
Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) Tetanus, reduced diphtheria, and acellular pertussis (TdaP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm. Other: Saline solution Subjects received one injection of saline solution at one month after vaccination.
BIOLOGICALLicensed TdaP booster (Boostrix®)
Licensed TdaP booster vaccine Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm. Other: Saline solution Subjects received one injection of saline solution at one month after vaccination.
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 43 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy individuals previously enrolled in V113\_01 trial, who completed the study following study protocol and who received the appropriate booster vaccine per group assignment * Individuals who voluntarily gave written informed consent after the nature of the study was explained according to local regulatory requirements, prior to study entry * Individuals who could comply with study procedures including follow-up
Exclusion criteria
1. Clinical conditions representing a contraindication to blood draw. 2. Abnormal function of the immune system resulting from: * Clinical conditions * Systemic administration of corticosteroids per oral (PO)/ intravenous (IV)/ intramuscular (IM) for more than 14 consecutive days within 90 days prior to informed consent. * Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. 3. Received immunoglobulins or any blood products within 180 days prior to informed consent. 4. Received an investigational or non-registered medicinal product within 30 days prior to informed consent 5. Study personnel as an immediate family or household member 6. Any other clinical condition that, in the opinion of the investigator, could interfere with the results of the study or pose additional risk to the subject due to participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | Day 1 | The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. |
| Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | Day 1 | The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D2aP1, T5D2aP2 and T5D2aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. |
| Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | Day 1 | The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D4aP1, T5D4aP2 and T5D4aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. |
| Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 | Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113\_01 time points to V113\_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. |
| Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 | Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113\_01 time points to V113\_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. |
| Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 | Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113\_01 time points to V113\_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. |
Countries
Belgium
Participant flow
Recruitment details
Subjects were enrolled at one site in Belgium. \- V113\_01 parent study number: NCT01529645
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Group aP1 Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study. | 27 |
| Group aP2 Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study. | 36 |
| Group aP4 Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study. | 32 |
| Group T5D2aP1 Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study. | 27 |
| Group T5D2aP2 Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study. | 33 |
| Group T5D2aP4 Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study. | 30 |
| Group T5D4aP1 Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study. | 37 |
| Group T5D4aP2 Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study. | 30 |
| Group T5D4aP4 Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study. | 30 |
| Licensed Tdap Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113\_01 and had blood collected at approximately 3 years later, in current V113\_01E1 study. | 33 |
| Total | 315 |
Baseline characteristics
| Characteristic | Group aP1 | Group aP2 | Group aP4 | Group T5D2aP1 | Group T5D2aP2 | Group T5D2aP4 | Group T5D4aP1 | Group T5D4aP2 | Group T5D4aP4 | Licensed Tdap | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 30.2 years STANDARD_DEVIATION 5.7 | 29.5 years STANDARD_DEVIATION 4.9 | 30.3 years STANDARD_DEVIATION 6.4 | 31.3 years STANDARD_DEVIATION 6.3 | 30.9 years STANDARD_DEVIATION 5.7 | 30 years STANDARD_DEVIATION 5.6 | 28.2 years STANDARD_DEVIATION 4.4 | 30.1 years STANDARD_DEVIATION 4.6 | 31.3 years STANDARD_DEVIATION 5.9 | 31.5 years STANDARD_DEVIATION 6.7 | 30.3 years STANDARD_DEVIATION 5.6 |
| Sex: Female, Male Female | 17 Participants | 25 Participants | 19 Participants | 11 Participants | 19 Participants | 16 Participants | 27 Participants | 13 Participants | 19 Participants | 21 Participants | 187 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 13 Participants | 16 Participants | 14 Participants | 14 Participants | 10 Participants | 17 Participants | 11 Participants | 12 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.
The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Time frame: Day 1
Population: Analysis were done on per protocol set (PPS) i.e., All subjects in the all enrolled set who provided immunogenicity data at V113\_01E1 visit 1 and:~* correctly received the vaccine in the V113\_01 parent study~* had no major protocol deviations leading to exclusion or were not excluded due to other reasons as defined prior to analysis
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | PT | 28 IU/mL |
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 206 IU/mL |
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 43 IU/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | PT | 31 IU/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 276 IU/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 54 IU/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 60 IU/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | PT | 48 IU/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 396 IU/mL |
| Licensed Tdap | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | PT | 18 IU/mL |
| Licensed Tdap | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 126 IU/mL |
| Licensed Tdap | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 63 IU/mL |
Primary
Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1.
The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D2aP1, T5D2aP2 and T5D2aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Time frame: Day 1
Population: Analysis were done on per protocol set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | PT | 17 IU/mL |
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 93 IU/mL |
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 41 IU/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | PT | 22 IU/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 248 IU/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 32 IU/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 51 IU/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | PT | 34 IU/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 373 IU/mL |
| Licensed Tdap | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | PT | 18 IU/mL |
| Licensed Tdap | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 126 IU/mL |
| Licensed Tdap | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 63 IU/mL |
Primary
Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1.
The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D4aP1, T5D4aP2 and T5D4aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Time frame: Day 1
Population: Analysis were done on per protocol set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | PT | 31 IU/mL |
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 247 IU/mL |
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 51 IU/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | PT | 31 IU/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 266 IU/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 48 IU/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | PT | 43 IU/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 58 IU/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 292 IU/mL |
| Licensed Tdap | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | PT | 18 IU/mL |
| Licensed Tdap | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | PRN | 126 IU/mL |
| Licensed Tdap | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | FHA | 63 IU/mL |
Primary
Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113\_01 time points to V113\_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Time frame: Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1
Population: Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113\_01E1/ Day 180 of V113\_01 PT, FHA and PRN was 27, 32, 31, 32 respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.39 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.64 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 2.93 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 11 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.83 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.45 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.30 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.68 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.48 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 7.21 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.33 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 2.25 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 1.06 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.62 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 1.66 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.30 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.34 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 15 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 1.00 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.69 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.45 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 3.25 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.63 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.95 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 1.50 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.47 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.63 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 7.63 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.24 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 1.31 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.26 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.32 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 11 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 1.60 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.42 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.56 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 2.75 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 0.93 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.65 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.78 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 20 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 0.85 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.27 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.47 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.59 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 0.62 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.67 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 4.28 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 0.88 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.42 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.21 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 3.36 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.29 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 1.00 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.72 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.79 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.54 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.26 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.48 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 6.61 Ratios |
Primary
Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113\_01 time points to V113\_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Time frame: Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1
Population: Analysis were done on per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 1.41 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.43 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.70 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.30 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 1.05 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 7.65 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 1.99 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.70 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 3.70 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.35 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 0.94 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.76 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.44 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.49 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.94 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.39 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.63 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 10 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.84 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.30 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.47 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.47 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.60 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.63 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.32 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 1.79 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 1.03 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 0.78 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 1.11 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 3.58 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.40 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 6.67 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 0.80 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.26 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.41 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.61 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 2.04 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 0.84 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.66 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.87 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 11 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 0.91 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.30 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.50 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.59 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 0.62 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 1.00 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 0.88 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 3.36 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.67 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 4.28 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.29 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.42 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.21 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.72 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.79 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.54 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.48 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 6.61 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.26 Ratios |
Primary
Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.
Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113\_01 time points to V113\_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups.
Time frame: Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1
Population: Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113\_01E1/ Day 180 of V113\_01 FHA and PRN was 33, 28, 28, 32 respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.78 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.45 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.81 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.57 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 0.85 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 2.09 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 1.02 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.67 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.33 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 1.24 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 3.40 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 8.76 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.99 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.60 Ratios |
| Group aP1 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.37 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 1.41 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 3.82 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 0.98 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.32 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.44 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.64 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 1.67 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 0.82 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.49 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.72 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.83 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 12 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.37 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.49 Ratios |
| Group aP2 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.64 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.58 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.50 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.48 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.48 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.79 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.32 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.97 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 13 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 5.90 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 1.11 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 1.11 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.33 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 2.19 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.65 Ratios |
| Group aP4 | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 0.99 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PT) | 0.42 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) | 3.36 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) | 0.26 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) | 0.88 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) | 0.62 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) | 0.72 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) | 0.54 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PT) | 0.21 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) | 0.48 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) | 0.79 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PT) | 4.28 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 365 of V113_01 (PT) | 0.67 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) | 0.29 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) | 6.61 Ratios |
| Licensed Tdap | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Day 1 of V113_01E1/ Day 8 of V113_01 (PT) | 1.00 Ratios |