Diphtheria, Lockjaw, Pertussis, Tetanus, Whooping Cough
Conditions
Keywords
pertussis, booster vaccine, tetanus, diphtheria in adults
Brief summary
This study will evaluate the safety and efficacy of 9 different vaccines containing aP (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy subjects 18 to 40 years of age.
Interventions
BIOLOGICALAcellular 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.
BIOLOGICALTetanus, 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.
BIOLOGICALLicensed TdaP booster vaccine
Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm.
BIOLOGICALDiphtheria 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.
OTHERSaline solution
Subjects received one injection of saline solution at one month after vaccination.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female individuals between 18 and 40 years of age (inclusive) who had provided informed consent. 2. Individuals who were able to be contacted for the duration of the study.
Exclusion criteria
1. Individuals who had received vaccines containing T, D, or pertussis (aP or whole cell), been diagnosed with pertussis disease, or who have had a household exposure to pertussis within the past 8 years. 2. If female, of childbearing potential, sexually active, and had not used any of the acceptable contraceptive methods for at least 2 months prior to study entry: 1. Of childbearing potential was defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy. 2. Acceptable birth control methods were defined as one or more of the following: * Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring); * Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse; * Intrauterine device (IUD); * Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry. 3. If female of childbearing potential and sexually active, refusal to use an acceptable contraceptive method through to 3 weeks after last study vaccination. 4. Any positive or indeterminate pregnancy test. 5. Female individuals who were pregnant or breastfeeding. 6. Individuals with contraindications, warnings and/or precautions to vaccination with Boostrix or Td-pur as specified within the summary of product characteristics. 7. Individuals with a clinically significant active infection (as assessed by the investigator) or oral body temperature ≥38°C/100.4ºF within 3 days of the intended date of vaccination. 8. Known hypersensitivity or allergy to diphtheria, tetanus, or pertussis vaccine (including excipients of the investigational study vaccines, control or placebo as summarized in protocol section 5.0). 9. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, might have interfered with the subject's ability to participate in the study. 10. Individuals with any progressive or severe neurologic disorder, seizure disorder or Guillian-Barré syndrome. 11. Individuals with history or any illness that, in the opinion of the investigator, might have interfered with the results of the study or pose additional risk to the individuals due to participation in the study. 12. Known or suspected impairment/alteration of immune function, including: 1. Chronic use of oral steroids (≥15 days of use) within 60 days prior to visit 1 (day 1) (use of inhaled, intranasal, or topical corticosteroids was allowed); 2. Receipt of parenteral steroids within 60 days prior to visit 1 (day 1); 3. Receipt of immunostimulants within 60 days prior to visit 1 (day 1); 4. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to visit 1 (day 1) or planned during the full length of the study; 5. HIV infection or HIV-related disease; 6. Heritable immunodeficiency. 13. Abnormalities of splenic or thymic function. 14. Individuals with a known bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time. 15. Individuals with any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). 16. Individuals with body mass index (BMI) greater than or equal to 35 kg/m2 (= weight in kg / (height in meters x height in meters)). 17. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or with intent to participate in another clinical study at any time during the conduct of this study. 18. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine other than Td or placebo within 28 days from the study vaccines. 19. Individuals who were first degree relatives of subjects involved in trial conduct. 20. Individuals with history of substance or alcohol abuse within the past 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (baseline) and Day 30 post vaccination | The percentages of subjects demonstrating diphtheria and tetanus antitoxin units \>= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator. |
| Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30 post vaccination/baseline (Day 1) | The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported. |
| GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30 post vaccination/baseline (Day 1) | The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported. |
| GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30 post vaccination/baseline (Day 1) | The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported. |
| The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Day 1 through 7 after vaccination | The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination. |
| The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | From day 1 to day 365 | The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination. |
| Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (baseline) and Day 30 post vaccination | The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported. |
| GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (baseline) and Day 30 post vaccination | The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported. |
| GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (baseline) and Day 30 post vaccination | The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (baseline) and Day 30 post vaccination | The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator. |
| GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30 post vaccination/Day 1 | The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported. |
| Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | Day 30 post vaccination | Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline. |
Countries
Belgium
Participant flow
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 day 1 of this study. | 42 |
| Group aP2 Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study. | 42 |
| Group aP4 Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study. | 42 |
| 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 and a fixed dose of tetanus toxoid) on day 1 of this study. | 42 |
| 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 day 1 of this study. | 42 |
| 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 day 1 of this study. | 42 |
| 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 day 1 of this study. | 42 |
| 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 day 1 of this study. | 42 |
| 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 day 1 of this study. | 42 |
| 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 day 1 of this study. | 42 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 1 | 1 | 0 | 2 | 0 | 1 | 0 |
| Overall Study | SAE - Premature contractions | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
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 | 26.6 years STANDARD_DEVIATION 5.6 | 26.8 years STANDARD_DEVIATION 5.1 | 27.4 years STANDARD_DEVIATION 6.5 | 26.8 years STANDARD_DEVIATION 5.7 | 27.7 years STANDARD_DEVIATION 5.9 | 25.8 years STANDARD_DEVIATION 5.2 | 25.1 years STANDARD_DEVIATION 4.2 | 27.5 years STANDARD_DEVIATION 5.1 | 27.2 years STANDARD_DEVIATION 5.6 | 27.4 years STANDARD_DEVIATION 6.4 | 26.8 years STANDARD_DEVIATION 5.5 |
| Sex: Female, Male Female | 24 Participants | 28 Participants | 25 Participants | 23 Participants | 27 Participants | 24 Participants | 29 Participants | 19 Participants | 27 Participants | 24 Participants | 250 Participants |
| Sex: Female, Male Male | 18 Participants | 14 Participants | 17 Participants | 19 Participants | 15 Participants | 18 Participants | 13 Participants | 23 Participants | 15 Participants | 18 Participants | 170 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 | 36 / 42 | 39 / 42 | 36 / 41 | 38 / 42 | 41 / 42 | 42 / 42 | 40 / 41 | 39 / 42 | 40 / 42 | 36 / 42 |
| serious Total, serious adverse events | 4 / 42 | 1 / 42 | 1 / 41 | 1 / 42 | 0 / 42 | 1 / 42 | 1 / 41 | 2 / 42 | 2 / 42 | 1 / 42 |
Outcome results
Primary
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported.
Time frame: Day 1 (baseline) and Day 30 post vaccination
Population: Analysis was done on the per-protocol population, ie, all subjects who correctly received the vaccine, 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 (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (FHA; N= 39,35,36,40) | 114 µg/mL |
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (FHA) | 20 µg/mL |
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PT) | 4.92 µg/mL |
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PRN; N= 39,35,36,40) | 589 µg/mL |
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PRN) | 20 µg/mL |
| Group aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PT; N= 39,35,36,40) | 91 µg/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (FHA) | 16 µg/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PT; N= 39,35,36,40) | 145 µg/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (FHA; N= 39,35,36,40) | 147 µg/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PRN; N= 39,35,36,40) | 936 µg/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PRN) | 16 µg/mL |
| Group aP2 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PT) | 3.81 µg/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PT; N= 39,35,36,40) | 182 µg/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PRN; N= 39,35,36,40) | 1384 µg/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PT) | 4.23 µg/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (FHA) | 21 µg/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (FHA; N= 39,35,36,40) | 183 µg/mL |
| Group aP4 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PRN) | 17 µg/mL |
| Group T5D2aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PRN; N= 39,35,36,40) | 475 µg/mL |
| Group T5D2aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (FHA; N= 39,35,36,40) | 241 µg/mL |
| Group T5D2aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (FHA) | 20 µg/mL |
| Group T5D2aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PT) | 5.07 µg/mL |
| Group T5D2aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PT; N= 39,35,36,40) | 87 µg/mL |
| Group T5D2aP1 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PRN) | 21 µg/mL |
Primary
Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported.
Time frame: Day 30 post vaccination/baseline (Day 1)
Population: Analysis was done on the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 18 Ratio |
| Group aP1 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 30 Ratio |
| Group aP1 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 5.49 Ratio |
| Group aP2 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 36 Ratio |
| Group aP2 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 58 Ratio |
| Group aP2 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 9.42 Ratio |
| Group aP4 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 9.39 Ratio |
| Group aP4 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 49 Ratio |
| Group aP4 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 81 Ratio |
| Group T5D2aP1 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 17 Ratio |
| Group T5D2aP1 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 24 Ratio |
| Group T5D2aP1 | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 12 Ratio |
Primary
GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
Time frame: Day 1 (baseline) and Day 30 post vaccination
Population: Analysis was done on the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (FHA; N= 41,38,38,40) | 83 µg/mL |
| Group aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PT) | 4.35 µg/mL |
| Group aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PRN; N= 41,38,38,40) | 445 µg/mL |
| Group aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PT; N= 41,38,38,40) | 62 µg/mL |
| Group aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (FHA) | 20 µg/mL |
| Group aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PRN) | 13 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PT) | 4.97 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (FHA; N= 41,38,38,40) | 90 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PT; N= 41,38,38,40) | 72 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PRN) | 21 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (FHA) | 16 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PRN; N= 41,38,38,40) | 803 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PRN; N= 41,38,38,40) | 1092 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PT) | 4.8 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (FHA; N= 41,38,38,40) | 118 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (FHA) | 23 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PRN) | 27 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PT; N= 41,38,38,40) | 160 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PT; N= 41,38,38,40) | 86 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (PRN; N= 41,38,38,40) | 496 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PT) | 5.07 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (FHA) | 20 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 30 (FHA; N= 41,38,38,40) | 241 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | Day 1 (PRN) | 21 µg/mL |
Primary
GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.
Time frame: Day 1 (baseline) and Day 30 post vaccination
Population: Analysis was done on the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (PT) | 83 µg/mL |
| Group aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (PRN) | 30 µg/mL |
| Group aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (FHA) | 24 µg/mL |
| Group aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (FHA) | 116 µg/mL |
| Group aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (PRN) | 837 µg/mL |
| Group aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (PT) | 8.74 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (PRN) | 680 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (FHA) | 100 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (FHA) | 27 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (PT) | 8.2 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (PRN) | 22 µg/mL |
| Group aP2 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (PT) | 93 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (PRN) | 1024 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (FHA) | 26 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (PRN) | 28 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (FHA) | 113 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (PT) | 8.06 µg/mL |
| Group aP4 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (PT) | 157 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (PRN) | 21 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (PRN) | 506 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (PT) | 93 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (FHA) | 20 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 1 (PT) | 5.07 µg/mL |
| Group T5D2aP1 | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | Day 30 (FHA) | 252 µg/mL |
Primary
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Time frame: Day 30 post vaccination/baseline (Day 1)
Population: Analysis was done on the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 9.51 Ratio |
| Group aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 27 Ratio |
| Group aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 4.7 Ratio |
| Group aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 12 Ratio |
| Group aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 32 Ratio |
| Group aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 3.95 Ratio |
| Group aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 4.39 Ratio |
| Group aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 20 Ratio |
| Group aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 36 Ratio |
| Group T5D2aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 17 Ratio |
| Group T5D2aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 24 Ratio |
| Group T5D2aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 12 Ratio |
Primary
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens
The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.
Time frame: Day 30 post vaccination/baseline (Day 1)
Population: Analysis was done on the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 14 Ratio |
| Group aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 30 Ratio |
| Group aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 4.24 Ratio |
| Group aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 15 Ratio |
| Group aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 38 Ratio |
| Group aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 5.02 Ratio |
| Group aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 5.11 Ratio |
| Group aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 31 Ratio |
| Group aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 46 Ratio |
| Group T5D2aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PT) | 17 Ratio |
| Group T5D2aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (PRN) | 24 Ratio |
| Group T5D2aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | Day 30/Day 1 (FHA) | 12 Ratio |
Primary
Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination
The percentages of subjects demonstrating diphtheria and tetanus antitoxin units \>= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator.
Time frame: Day 1 (baseline) and Day 30 post vaccination
Population: Analysis was done on the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 98 percentages of subjects |
| Group aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 79 percentages of subjects |
| Group aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (diphteria) | 87 percentages of subjects |
| Group aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (tetanus) | 100 percentages of subjects |
| Group aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 89 percentages of subjects |
| Group aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (diphteria) | 97 percentages of subjects |
| Group aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (tetanus) | 100 percentages of subjects |
| Group aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 100 percentages of subjects |
| Group aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (diphteria) | 81 percentages of subjects |
| Group aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 72 percentages of subjects |
| Group aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (tetanus) | 100 percentages of subjects |
| Group aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 100 percentages of subjects |
| Group T5D2aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (diphteria) | 98 percentages of subjects |
| Group T5D2aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 71 percentages of subjects |
| Group T5D2aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (tetanus) | 100 percentages of subjects |
| Group T5D2aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 100 percentages of subjects |
| Group T5D2aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 100 percentages of subjects |
| Group T5D2aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 68 percentages of subjects |
| Group T5D2aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (tetanus) | 100 percentages of subjects |
| Group T5D2aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (diphteria) | 97 percentages of subjects |
| Group T5D2aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 95 percentages of subjects |
| Group T5D2aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (diphteria) | 95 percentages of subjects |
| Group T5D2aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (tetanus) | 97 percentages of subjects |
| Group T5D2aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 85 percentages of subjects |
| Group T5D4aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (diphteria) | 100 percentages of subjects |
| Group T5D4aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (tetanus) | 100 percentages of subjects |
| Group T5D4aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 100 percentages of subjects |
| Group T5D4aP1 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 81 percentages of subjects |
| Group T5D4aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (diphteria) | 100 percentages of subjects |
| Group T5D4aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 72 percentages of subjects |
| Group T5D4aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 100 percentages of subjects |
| Group T5D4aP2 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (tetanus) | 100 percentages of subjects |
| Group T5D4aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 98 percentages of subjects |
| Group T5D4aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (diphteria) | 100 percentages of subjects |
| Group T5D4aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 78 percentages of subjects |
| Group T5D4aP4 | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (tetanus) | 100 percentages of subjects |
| Licensed TdaP | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 95 percentages of subjects |
| Licensed TdaP | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (diphteria) | 100 percentages of subjects |
| Licensed TdaP | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 30 (tetanus) | 100 percentages of subjects |
| Licensed TdaP | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 80 percentages of subjects |
Primary
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination.
Time frame: Day 1 through 7 after vaccination
Population: Analysis was done on the safety set, ie, all subjects who received the study vaccination and provided post vaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site induration | 3 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Prophylactic use of analgesic/antipyretic | 0 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Other | 6 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Nausea | 3 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Body temperature (≥40°C) | 0 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized arthralgia | 2 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Therapeutic use of analgesic/antipyretic | 6 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any local | 30 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Fatigue | 19 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized myalgia | 10 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pain | 30 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Systemic | 27 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site erythema | 0 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pruritus | 0 participants |
| Group aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Headache | 17 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Body temperature (≥40°C) | 0 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized myalgia | 8 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site erythema | 1 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pruritus | 4 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Nausea | 6 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Therapeutic use of analgesic/antipyretic | 7 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any local | 33 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Headache | 13 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized arthralgia | 0 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Fatigue | 14 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site induration | 3 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Prophylactic use of analgesic/antipyretic | 1 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Other | 7 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Systemic | 20 participants |
| Group aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pain | 32 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Therapeutic use of analgesic/antipyretic | 2 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pruritus | 1 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Nausea | 2 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Prophylactic use of analgesic/antipyretic | 0 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized myalgia | 4 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized arthralgia | 3 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Fatigue | 13 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Headache | 12 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any local | 32 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Other | 2 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Body temperature (≥40°C) | 0 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site induration | 1 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site erythema | 1 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pain | 31 participants |
| Group aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Systemic | 20 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Prophylactic use of analgesic/antipyretic | 0 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site induration | 6 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Headache | 8 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Fatigue | 13 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized arthralgia | 4 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized myalgia | 8 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site erythema | 1 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Nausea | 1 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Body temperature (≥40°C) | 0 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Systemic | 18 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pruritus | 3 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pain | 35 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any local | 35 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Therapeutic use of analgesic/antipyretic | 6 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Other | 6 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized myalgia | 10 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Other | 8 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Body temperature (≥40°C) | 0 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Headache | 13 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Therapeutic use of analgesic/antipyretic | 8 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any local | 38 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site erythema | 2 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site induration | 1 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pruritus | 2 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Prophylactic use of analgesic/antipyretic | 1 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Systemic | 20 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Nausea | 2 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Fatigue | 15 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pain | 38 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized arthralgia | 1 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Nausea | 5 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site induration | 7 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Fatigue | 18 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Other | 4 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Therapeutic use of analgesic/antipyretic | 3 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Body temperature (≥40°C) | 0 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized arthralgia | 3 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Prophylactic use of analgesic/antipyretic | 1 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Systemic | 23 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pain | 36 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site erythema | 6 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized myalgia | 11 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pruritus | 5 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any local | 37 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Headache | 13 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pain | 40 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site erythema | 3 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Other | 8 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any local | 40 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Nausea | 4 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Therapeutic use of analgesic/antipyretic | 8 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized arthralgia | 4 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Headache | 16 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Fatigue | 20 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Systemic | 27 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized myalgia | 12 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Body temperature (≥40°C) | 0 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pruritus | 3 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Prophylactic use of analgesic/antipyretic | 2 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site induration | 9 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any local | 36 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pruritus | 3 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized myalgia | 8 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Systemic | 21 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site induration | 4 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site erythema | 2 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Prophylactic use of analgesic/antipyretic | 1 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized arthralgia | 4 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Nausea | 6 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Headache | 14 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Fatigue | 15 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Other | 7 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Therapeutic use of analgesic/antipyretic | 7 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pain | 35 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Body temperature (≥40°C) | 0 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized arthralgia | 7 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Headache | 17 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Prophylactic use of analgesic/antipyretic | 2 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any local | 39 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site erythema | 4 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site induration | 4 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pruritus | 6 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pain | 39 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Systemic | 27 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Nausea | 7 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Fatigue | 16 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized myalgia | 9 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Other | 7 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Body temperature (≥40°C) | 0 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Therapeutic use of analgesic/antipyretic | 7 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized arthralgia | 1 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Generalized myalgia | 11 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Fatigue | 12 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Systemic | 21 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pain | 31 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site pruritus | 5 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site induration | 6 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Injection site erythema | 3 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any local | 33 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Prophylactic use of analgesic/antipyretic | 1 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any Other | 8 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Headache | 13 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Nausea | 1 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Therapeutic use of analgesic/antipyretic | 8 participants |
| Licensed TdaP | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Body temperature (≥40°C) | 0 participants |
Primary
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination.
Time frame: From day 1 to day 365
Population: Analysis was done on the safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any AE (day 1 to 30) | 20 participants |
| Group aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any SAE (Day1 to Day 365) | 4 participants |
| Group aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Death | 0 participants |
| Group aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related unsolicited AEs | 11 participants |
| Group aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | AEs leading to withdrawal (Day1 to Day 365) | 0 participants |
| Group aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related SAEs | 0 participants |
| Group aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | AEs leading to withdrawal (Day1 to Day 365) | 0 participants |
| Group aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related SAEs | 0 participants |
| Group aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Death | 0 participants |
| Group aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any AE (day 1 to 30) | 28 participants |
| Group aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any SAE (Day1 to Day 365) | 1 participants |
| Group aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related unsolicited AEs | 13 participants |
| Group aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related SAEs | 0 participants |
| Group aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any SAE (Day1 to Day 365) | 1 participants |
| Group aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related unsolicited AEs | 7 participants |
| Group aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | AEs leading to withdrawal (Day1 to Day 365) | 0 participants |
| Group aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Death | 0 participants |
| Group aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any AE (day 1 to 30) | 12 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related unsolicited AEs | 8 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Death | 0 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any AE (day 1 to 30) | 21 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related SAEs | 0 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any SAE (Day1 to Day 365) | 1 participants |
| Group T5D2aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | AEs leading to withdrawal (Day1 to Day 365) | 0 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | AEs leading to withdrawal (Day1 to Day 365) | 0 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related unsolicited AEs | 9 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Death | 0 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any AE (day 1 to 30) | 13 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related SAEs | 0 participants |
| Group T5D2aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any SAE (Day1 to Day 365) | 0 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | AEs leading to withdrawal (Day1 to Day 365) | 0 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related unsolicited AEs | 11 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Death | 0 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any AE (day 1 to 30) | 17 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related SAEs | 0 participants |
| Group T5D2aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any SAE (Day1 to Day 365) | 1 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any SAE (Day1 to Day 365) | 1 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | AEs leading to withdrawal (Day1 to Day 365) | 0 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any AE (day 1 to 30) | 16 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related unsolicited AEs | 7 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related SAEs | 0 participants |
| Group T5D4aP1 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Death | 0 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Death | 0 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related SAEs | 0 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any AE (day 1 to 30) | 14 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related unsolicited AEs | 4 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any SAE (Day1 to Day 365) | 2 participants |
| Group T5D4aP2 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | AEs leading to withdrawal (Day1 to Day 365) | 0 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related SAEs | 0 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any SAE (Day1 to Day 365) | 2 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related unsolicited AEs | 11 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | AEs leading to withdrawal (Day1 to Day 365) | 0 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any AE (day 1 to 30) | 18 participants |
| Group T5D4aP4 | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Death | 0 participants |
| Licensed TdaP | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any AE (day 1 to 30) | 18 participants |
| Licensed TdaP | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related SAEs | 0 participants |
| Licensed TdaP | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Death | 0 participants |
| Licensed TdaP | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | Any SAE (Day1 to Day 365) | 1 participants |
| Licensed TdaP | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | AEs leading to withdrawal (Day1 to Day 365) | 0 participants |
| Licensed TdaP | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | At least possibly related unsolicited AEs | 10 participants |
Secondary
GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination
The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator.
Time frame: Day 1 (baseline) and Day 30 post vaccination
Population: Analysis was done on the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 0.4 IU/mL |
| Group aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (diphteria) | 0.39 IU/mL |
| Group aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 2.45 IU/mL |
| Group aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (tetanus) | 2.19 IU/mL |
| Group aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (diphteria) | 0.39 IU/mL |
| Group aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 0.43 IU/mL |
| Group aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (tetanus) | 2.18 IU/mL |
| Group aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 2.11 IU/mL |
| Group aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (diphteria) | 0.37 IU/mL |
| Group aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 0.25 IU/mL |
| Group aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 2.27 IU/mL |
| Group aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (tetanus) | 2.19 IU/mL |
| Group T5D2aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 0.31 IU/mL |
| Group T5D2aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (diphteria) | 1.48 IU/mL |
| Group T5D2aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 1.93 IU/mL |
| Group T5D2aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (tetanus) | 8.15 IU/mL |
| Group T5D2aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 1.99 IU/mL |
| Group T5D2aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (diphteria) | 1.41 IU/mL |
| Group T5D2aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (tetanus) | 8.82 IU/mL |
| Group T5D2aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 0.15 IU/mL |
| Group T5D2aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 2.07 IU/mL |
| Group T5D2aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (diphteria) | 1.63 IU/mL |
| Group T5D2aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 0.29 IU/mL |
| Group T5D2aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (tetanus) | 7.01 IU/mL |
| Group T5D4aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (diphteria) | 2.7 IU/mL |
| Group T5D4aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 2.04 IU/mL |
| Group T5D4aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (tetanus) | 8.23 IU/mL |
| Group T5D4aP1 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 0.31 IU/mL |
| Group T5D4aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 0.25 IU/mL |
| Group T5D4aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (tetanus) | 6.82 IU/mL |
| Group T5D4aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (diphteria) | 2.19 IU/mL |
| Group T5D4aP2 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 2.62 IU/mL |
| Group T5D4aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (tetanus) | 7.44 IU/mL |
| Group T5D4aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 0.25 IU/mL |
| Group T5D4aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 1.92 IU/mL |
| Group T5D4aP4 | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (diphteria) | 2.47 IU/mL |
| Licensed TdaP | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (tetanus; N=42,38,39,41,38,40,37,39,40,40) | 1.89 IU/mL |
| Licensed TdaP | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 1 (diphteria; N=42,38,39,41,38,40,37,39,40,40) | 0.3 IU/mL |
| Licensed TdaP | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (tetanus) | 8.49 IU/mL |
| Licensed TdaP | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | Day 30 (diphteria) | 1.79 IU/mL |
Secondary
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens
The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported.
Time frame: Day 30 post vaccination/Day 1
Population: Analysis was done on the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (diphtheria) | 1.05 Ratio |
| Group aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (tetanus) | 0.94 Ratio |
| Group aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (diphtheria) | 1.05 Ratio |
| Group aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (tetanus) | 0.92 Ratio |
| Group aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (diphtheria) | 1.19 Ratio |
| Group aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (tetanus) | 0.97 Ratio |
| Group T5D2aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (diphtheria) | 5.24 Ratio |
| Group T5D2aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (tetanus) | 4.2 Ratio |
| Group T5D2aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (tetanus) | 4.43 Ratio |
| Group T5D2aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (diphtheria) | 8.58 Ratio |
| Group T5D2aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (tetanus) | 3.43 Ratio |
| Group T5D2aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (diphtheria) | 5.62 Ratio |
| Group T5D4aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (tetanus) | 4.02 Ratio |
| Group T5D4aP1 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (diphtheria) | 9.18 Ratio |
| Group T5D4aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (diphtheria) | 8.39 Ratio |
| Group T5D4aP2 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (tetanus) | 2.64 Ratio |
| Group T5D4aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (diphtheria) | 9.54 Ratio |
| Group T5D4aP4 | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (tetanus) | 3.86 Ratio |
| Licensed TdaP | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (diphtheria) | 6.1 Ratio |
| Licensed TdaP | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | Day 30/day 1 (tetanus) | 4.5 Ratio |
Secondary
Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.
Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline.
Time frame: Day 30 post vaccination
Population: Analysis was done on the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (FHA) | 85 percentage of subjects |
| Group aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (FHA) | 59 percentage of subjects |
| Group aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PRN) | 100 percentage of subjects |
| Group aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PT) | 92 percentage of subjects |
| Group aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PRN) | 92 percentage of subjects |
| Group aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PT) | 100 percentage of subjects |
| Group aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (FHA) | 94 percentage of subjects |
| Group aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PT) | 100 percentage of subjects |
| Group aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PT) | 100 percentage of subjects |
| Group aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PRN) | 100 percentage of subjects |
| Group aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PRN) | 100 percentage of subjects |
| Group aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (FHA) | 83 percentage of subjects |
| Group aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (FHA) | 89 percentage of subjects |
| Group aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PRN) | 100 percentage of subjects |
| Group aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PT) | 94 percentage of subjects |
| Group aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PT) | 92 percentage of subjects |
| Group aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PRN) | 100 percentage of subjects |
| Group aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (FHA) | 83 percentage of subjects |
| Group T5D2aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PT) | 80 percentage of subjects |
| Group T5D2aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (FHA) | 46 percentage of subjects |
| Group T5D2aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (FHA) | 80 percentage of subjects |
| Group T5D2aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PRN) | 98 percentage of subjects |
| Group T5D2aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PT) | 95 percentage of subjects |
| Group T5D2aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PRN) | 90 percentage of subjects |
| Group T5D2aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PRN) | 100 percentage of subjects |
| Group T5D2aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PT) | 95 percentage of subjects |
| Group T5D2aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PT) | 76 percentage of subjects |
| Group T5D2aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (FHA) | 95 percentage of subjects |
| Group T5D2aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (FHA) | 61 percentage of subjects |
| Group T5D2aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PRN) | 95 percentage of subjects |
| Group T5D2aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PT) | 100 percentage of subjects |
| Group T5D2aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PT) | 100 percentage of subjects |
| Group T5D2aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PRN) | 100 percentage of subjects |
| Group T5D2aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (FHA) | 58 percentage of subjects |
| Group T5D2aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PRN) | 97 percentage of subjects |
| Group T5D2aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (FHA) | 95 percentage of subjects |
| Group T5D4aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PT) | 81 percentage of subjects |
| Group T5D4aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (FHA) | 46 percentage of subjects |
| Group T5D4aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PRN) | 89 percentage of subjects |
| Group T5D4aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (FHA) | 76 percentage of subjects |
| Group T5D4aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PT) | 89 percentage of subjects |
| Group T5D4aP1 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PRN) | 97 percentage of subjects |
| Group T5D4aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (FHA) | 77 percentage of subjects |
| Group T5D4aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PT) | 90 percentage of subjects |
| Group T5D4aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (FHA) | 56 percentage of subjects |
| Group T5D4aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PRN) | 92 percentage of subjects |
| Group T5D4aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PRN) | 85 percentage of subjects |
| Group T5D4aP2 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PT) | 77 percentage of subjects |
| Group T5D4aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (FHA) | 90 percentage of subjects |
| Group T5D4aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PT) | 93 percentage of subjects |
| Group T5D4aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PRN) | 98 percentage of subjects |
| Group T5D4aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (FHA) | 53 percentage of subjects |
| Group T5D4aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PT) | 95 percentage of subjects |
| Group T5D4aP4 | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PRN) | 100 percentage of subjects |
| Licensed TdaP | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PRN) | 90 percentage of subjects |
| Licensed TdaP | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PRN) | 100 percentage of subjects |
| Licensed TdaP | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (PT) | 100 percentage of subjects |
| Licensed TdaP | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (FHA) | 83 percentage of subjects |
| Licensed TdaP | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 4-Fold (PT) | 98 percentage of subjects |
| Licensed TdaP | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | 2-Fold (FHA) | 95 percentage of subjects |