Diphtheria, Pertussis, Tetanus
Conditions
Keywords
Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL
Brief summary
Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this formulation as a 5th dose. Primary Objective: \- To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years. Secondary/Observational Objectives: * To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine (for pertussis antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years. * To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after each long-term follow-up. * To describe the safety profile following vaccine administration.
Interventions
BIOLOGICALTdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
0.5 mL, IM
BIOLOGICALDTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
0.5 mL, IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
: * Healthy, as determined by medical history and physical examination. * Aged 4 to 6 (\< 7) years at the time of study vaccination on Day 0. * Signed and dated informed consent form that has been approved by the Institutional Review Board (IRB) by the parent or legally authorized representative. * Signed and dated informed assent form from the subject if required by the IRB. * Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all trial procedures. Subjects will be invited to participate in the long-term immunogenicity follow-up study but a commitment to participate in the long-term is not required as an inclusion criterion. * Documented vaccination history of 4 previous doses of DAPTACEL according to the recommended national immunization schedule for Diphtheria, tetanus and acellular pertussis (DTaP).
Exclusion criteria
: * Participation in another clinical trial in the 4 weeks preceding the trial vaccination. * Planned participation in another clinical trial during the original trial period. * Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. * Systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the trial vaccine or a vaccine containing the same substances. * Chronic illness at a stage that could interfere with trial conduct or completion. * Blood or blood-derived products received in the past 3 months. * Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (with the exception of the annual influenza vaccine). * History of diphtheria, tetanus or pertussis infection (confirmed either serologically or microbiologically). * Thrombocytopenia or bleeding disorder contraindicating intra muscular vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level | Pre-dose and 30 days post-vaccination | Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA). |
| Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL | Pre-dose and 30 days post-vaccination | Serothreshold rate at level ≥ 1.0 IU/mL was defined as antibody concentrations ≥ 1.0 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA). |
| Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis | 30 Days post-vaccination | Booster response was defined as post titer ≥ 0.4 IU/mL and pre-titer \< 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre titer ≥ 0.1 IU/mL but \< 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). |
| Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus | 30 Days post-vaccination | Booster response was defined as post titer ≥ 0.4 IU/mL and pre titer \< 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre-titer ≥ 0.1 IU/mL but \< 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL. Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA). |
| Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Pre-dose and 30 Days Post-vaccination | Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Days 0 to 7 post-vaccination | Solicited Injection Site Reactions: Pain, erythema/redness, swelling, increased left limb circumference, and increased right limb circumference. Solicited Systemic Reactions: Fever (temperature), headache, malaise, and myalgia. |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were enrolled from 13 April 2007 to 16 October 2009 in 42 clinical centers in the US and 1 clinical center in Canada.
Pre-assignment details
A total of 1042 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Tdap Vaccine Group Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap). | 531 |
| DTaP Vaccine Group Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP). | 511 |
| Total | 1,042 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 9 |
| Overall Study | Protocol Violation | 8 | 4 |
| Overall Study | Withdrawal by Subject | 4 | 10 |
Baseline characteristics
| Characteristic | Tdap Vaccine Group | DTaP Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 531 Participants | 511 Participants | 1042 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.45 Years STANDARD_DEVIATION 0.48 | 4.42 Years STANDARD_DEVIATION 0.47 | 4.44 Years STANDARD_DEVIATION 0.48 |
| Region of Enrollment Canada | 9 participants | 9 participants | 18 participants |
| Region of Enrollment United States | 522 participants | 502 participants | 1024 participants |
| Sex: Female, Male Female | 275 Participants | 244 Participants | 519 Participants |
| Sex: Female, Male Male | 256 Participants | 267 Participants | 523 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 318 / 531 | 353 / 511 |
| serious Total, serious adverse events | 4 / 531 | 5 / 511 |
Outcome results
Primary
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Pre-dose and 30 Days Post-vaccination
Population: Geometric mean titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Tdap Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Pertussis Toxoid, Pre-dose [n = 411, 390] | 4.58 EU/mL |
| Tdap Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Pertussis Toxoid, Post-dose [n = 430, 423] | 53.1 EU/mL |
| Tdap Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Filamentous Haemagglutinin, Pre-dose [n= 435, 408] | 7.56 EU/mL |
| Tdap Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Filamentous Haemagglutinin, Post-dose [n=439, 424] | 102 EU/mL |
| Tdap Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Pertactin, Pre-dose [n = 442, 424] | 9.31 EU/mL |
| Tdap Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Pertactin, Post-dose [n = 441, 425] | 121 EU/mL |
| Tdap Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Fimbriae types 2 and 3, Pre-dose [n = 434, 420] | 23.8 EU/mL |
| Tdap Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Fimbriae types 2 and 3, Post-dose [n = 439, 424] | 425 EU/mL |
| DTaP Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Fimbriae types 2 and 3, Post-dose [n = 439, 424] | 388 EU/mL |
| DTaP Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Pertussis Toxoid, Pre-dose [n = 411, 390] | 4.98 EU/mL |
| DTaP Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Pertactin, Pre-dose [n = 442, 424] | 11.1 EU/mL |
| DTaP Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Pertussis Toxoid, Post-dose [n = 430, 423] | 86.4 EU/mL |
| DTaP Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Fimbriae types 2 and 3, Pre-dose [n = 434, 420] | 24.4 EU/mL |
| DTaP Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Filamentous Haemagglutinin, Pre-dose [n= 435, 408] | 7.60 EU/mL |
| DTaP Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Pertactin, Post-dose [n = 441, 425] | 173 EU/mL |
| DTaP Vaccine Group | Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis | Filamentous Haemagglutinin, Post-dose [n=439, 424] | 86.5 EU/mL |
Primary
Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level
Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Pre-dose and 30 days post-vaccination
Population: Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap Vaccine Group | Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level | Diphtheria (IU/mL), Pre-dose [n = 442, 425] | 65 Percentage of Participants |
| Tdap Vaccine Group | Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level | Diphtheria (IU/mL), Post-dose [n = 442, 426] | 100 Percentage of Participants |
| Tdap Vaccine Group | Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level | Tetanus (IU/mL), Pre-dose [n = 442, 426] | 81 Percentage of Participants |
| Tdap Vaccine Group | Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level | Tetanus (IU/mL), Post-dose [n = 442, 426] | 100 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level | Tetanus (IU/mL), Post-dose [n = 442, 426] | 100 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level | Diphtheria (IU/mL), Pre-dose [n = 442, 425] | 69 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level | Tetanus (IU/mL), Pre-dose [n = 442, 426] | 85 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level | Diphtheria (IU/mL), Post-dose [n = 442, 426] | 100 Percentage of Participants |
Primary
Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL
Serothreshold rate at level ≥ 1.0 IU/mL was defined as antibody concentrations ≥ 1.0 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Pre-dose and 30 days post-vaccination
Population: Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap Vaccine Group | Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL | Diphtheria (IU/mL), Pre-dose | 4 Percentage of Participants |
| Tdap Vaccine Group | Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL | Diphtheria (IU/mL), Post-dose | 99 Percentage of Participants |
| Tdap Vaccine Group | Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL | Tetanus (IU/mL), Pre-dose | 11 Percentage of Participants |
| Tdap Vaccine Group | Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL | Tetanus (IU/mL), Post-dose | 97 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL | Tetanus (IU/mL), Post-dose | 98 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL | Diphtheria (IU/mL), Pre-dose | 7 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL | Tetanus (IU/mL), Pre-dose | 12 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL | Diphtheria (IU/mL), Post-dose | 100 Percentage of Participants |
Primary
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus
Booster response was defined as post titer ≥ 0.4 IU/mL and pre titer \< 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre-titer ≥ 0.1 IU/mL but \< 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL. Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA).
Time frame: 30 Days post-vaccination
Population: Diphtheria and tetanus antibody booster response were analysed in all enrolled and vaccinated participants, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus | Diphtheria (IU/mL) [n = 442, 425] | 99 Percentage of Participants |
| Tdap Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus | Tetanus (IU/mL) [n = 442, 426] | 98 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus | Diphtheria (IU/mL) [n = 442, 425] | 99 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus | Tetanus (IU/mL) [n = 442, 426] | 97 Percentage of Participants |
Primary
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis
Booster response was defined as post titer ≥ 0.4 IU/mL and pre-titer \< 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre titer ≥ 0.1 IU/mL but \< 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: 30 Days post-vaccination
Population: Pertussis antibody booster response analysis was in all enrolled and vaccinated participants in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis | Pertussis Toxoid (EU/mL) [n = 401, 387] | 88 Percentage of Participants |
| Tdap Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis | Filamentous Haemagglutinin (EU/mL) [n = 432, 407] | 92 Percentage of Participants |
| Tdap Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis | Pertactin (EU/mL) [n = 441, 423] | 92 Percentage of Participants |
| Tdap Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis | Fimbriae types 2 and 3 (EU/mL) [n = 432, 418] | 95 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis | Fimbriae types 2 and 3 (EU/mL) [n = 432, 418] | 94 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis | Pertussis Toxoid (EU/mL) [n = 401, 387] | 94 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis | Pertactin (EU/mL) [n = 441, 423] | 95 Percentage of Participants |
| DTaP Vaccine Group | Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis | Filamentous Haemagglutinin (EU/mL) [n = 432, 407] | 89 Percentage of Participants |
Other Pre-specified
Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination
Solicited Injection Site Reactions: Pain, erythema/redness, swelling, increased left limb circumference, and increased right limb circumference. Solicited Systemic Reactions: Fever (temperature), headache, malaise, and myalgia.
Time frame: Days 0 to 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Solicited Injection Site Reaction [n=529, 495] | 455 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Pain [n = 529, 495] | 318 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Pain (Incapacitating) | 1 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Erythema [n = 529, 494] | 140 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Erythema (> 50 mm) | 17 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Swelling [n = 529, 493] | 100 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Swelling (> 50 mm) | 8 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Increased Left Limb Circumference [n=527, 494] | 309 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Left Limb Circumference (> 40 mm increase) | 1 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Increased Right Limb Circumference [n=527, 494 | 241 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Right Limb Circumerence (> 40 mm increase) | 1 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Solicited System Reaction [n = 529, 495] | 256 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Fever [n = 527, 493] | 25 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Fever (> 39.5 °C) | 1 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Headache [n = 529, 495] | 60 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Headache (Prevents daily activities) | 3 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Malaise [n = 529, 495] | 143 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Malaise (Prevents daily activities) | 5 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Myalgia [n = 529, 495] | 185 Participants |
| Tdap Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Myalgia (Prevents daily activities) | 3 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Malaise (Prevents daily activities) | 7 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Solicited Injection Site Reaction [n=529, 495] | 451 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Right Limb Circumerence (> 40 mm increase) | 0 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Pain [n = 529, 495] | 334 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Headache (Prevents daily activities) | 4 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Pain (Incapacitating) | 4 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Solicited System Reaction [n = 529, 495] | 260 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Erythema [n = 529, 494] | 201 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Myalgia (Prevents daily activities) | 8 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Erythema (> 50 mm) | 65 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Fever [n = 527, 493] | 26 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Swelling [n = 529, 493] | 144 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Malaise [n = 529, 495] | 150 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Swelling (> 50 mm) | 23 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Fever (> 39.5 °C) | 1 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Increased Left Limb Circumference [n=527, 494] | 353 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Myalgia [n = 529, 495] | 196 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Grade 3 Left Limb Circumference (> 40 mm increase) | 5 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Headache [n = 529, 495] | 74 Participants |
| DTaP Vaccine Group | Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination | Any Increased Right Limb Circumference [n=527, 494 | 244 Participants |