Diphtheria, Pertussis, Tetanus
Conditions
Keywords
Pertussis, Tetanus, Diphtheria, Tdap
Brief summary
It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no upper limit on its age indication. The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine among individuals ≥ 65 years of age.
Interventions
BIOLOGICALADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
BIOLOGICALDECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
0.5 mL, IM
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Ambulatory and not institutionalized. * At least 65 years of age at the time of vaccination. * Signed Institutional Review Board (IRB)-approved informed consent form. * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
: * Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine. * Serious chronic disease (eg, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that, in the opinion of the investigator, might: * interfere with the ability to participate fully in the study; or * interfere with evaluation of the vaccine. * Known or suspected impairment of immunologic function, including use of immune suppressive medications (eg, rheumatoid arthritis drugs such as methotrexate; cancer chemotherapy agents such as vincristine). * Febrile illness within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at the time of inclusion. * Any history of documented tetanus, diphtheria or pertussis disease. * Known or suspected receipt of a tetanus, diphtheria or acellular pertussis containing vaccine within the preceding 5 years. * Administration of immune globulin or other blood products within the last three months, or systemic corticosteroid therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 6 months. * Systemic antibiotic therapy within the 72 hours prior to enrollment. * Received any vaccine, other than influenza vaccine, in the 30-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 35-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment. * Suspected or known hypersensitivity to any of the vaccine components. * Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study. * Use of alcohol or drugs in a manner that may, in the opinion of the investigator, interfere with the subject's ability to comply with trial visits or procedures. * Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent, or requires a legally authorized representative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Day 35 post-vaccination | — |
| Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®. | Day 35 post-vaccination | Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL. |
| Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine. | Day 35 post-vaccination | Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Day 0 up to 14 days post-vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 28 March to 30 October 2007, at 19 clinic centers in United States.
Pre-assignment details
A total of 1563 participants were enrolled; 1561 were vaccinated with data analyzed and presented in this report.
Participants by arm
| Arm | Count |
|---|---|
| ADACEL® Vaccine Group Participants received a single dose of ADACEL® vaccine. | 1,170 |
| DECAVAC® Vaccine Group Participants received a single dose of ADACEL® vaccine. | 391 |
| Total | 1,561 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Protocol Violation | 4 | 1 |
| Overall Study | Serious Adverse Events | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Total | ADACEL® Vaccine Group | DECAVAC® Vaccine Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1561 Participants | 1170 Participants | 391 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 72.2 Years STANDARD_DEVIATION 5.71 | 72.2 Years STANDARD_DEVIATION 5.74 | 72.3 Years STANDARD_DEVIATION 5.63 |
| Region of Enrollment United States | 1561 participants | 1170 participants | 391 participants |
| Sex: Female, Male Female | 777 Participants | 579 Participants | 198 Participants |
| Sex: Female, Male Male | 784 Participants | 591 Participants | 193 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 615 / 1,170 | 200 / 391 |
| serious Total, serious adverse events | 49 / 1,170 | 20 / 391 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine
Time frame: Day 35 post-vaccination
Population: GMTs and their 95% Confidence Intervals were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Tetanus (Pre-vaccination: N = 1089; 368) | 0.501 Titers |
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Tetanus (Post-vaccination: N = 1075; 368) | 8.43 Titers |
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Diphtheria (Pre-vaccination: N = 1092; 370) | 0.049 Titers |
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Diphtheria (Post-vaccination: N = 1093; 371) | 0.570 Titers |
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Pertussis Toxoid (Pre-vaccination: N = 1013; 345) | 10.6 Titers |
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Pertussis Toxoid (Post-vaccination: N = 1022; 341) | 59.4 Titers |
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Filamentous Hemagglutinin (Pre-vacc: N=1091; 370) | 25.5 Titers |
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Filamentous Hemagglutinin (Post-Vacc: N=1094; 371) | 197 Titers |
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Pertactin (Pre-Vaccination: N = 1090; 370) | 4.56 Titers |
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Pertactin (Post-Vaccination: N = 1094; 370) | 69.2 Titers |
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Fimbriae Type 2 & 3 (Pre-Vaccination: N=1053; 370) | 8.28 Titers |
| ADACEL® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Fimbriae Type 2 & 3 (Post-Vaccination: N=1060; 352 | 183 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Fimbriae Type 2 & 3 (Pre-Vaccination: N=1053; 370) | 9.59 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Tetanus (Pre-vaccination: N = 1089; 368) | 0.451 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Filamentous Hemagglutinin (Pre-vacc: N=1091; 370) | 25.6 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Tetanus (Post-vaccination: N = 1075; 368) | 7.23 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Pertactin (Post-Vaccination: N = 1094; 370) | 5.34 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Diphtheria (Pre-vaccination: N = 1092; 370) | 0.056 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Filamentous Hemagglutinin (Post-Vacc: N=1094; 371) | 26.6 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Diphtheria (Post-vaccination: N = 1093; 371) | 0.505 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Fimbriae Type 2 & 3 (Post-Vaccination: N=1060; 352 | 10.6 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Pertussis Toxoid (Pre-vaccination: N = 1013; 345) | 12.7 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Pertactin (Pre-Vaccination: N = 1090; 370) | 4.71 Titers |
| DECAVAC® Vaccine Group | Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine | Pertussis Toxoid (Post-vaccination: N = 1022; 341) | 15 Titers |
Primary
Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine.
Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value.
Time frame: Day 35 post-vaccination
Population: Booster response was assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADACEL® Vaccine Group | Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine. | Tetanus (N = 1071; 365) | 77 Percentage of Participants |
| ADACEL® Vaccine Group | Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine. | Diphtheria (N = 1091; 370) | 71 Percentage of Participants |
| DECAVAC® Vaccine Group | Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine. | Tetanus (N = 1071; 365) | 77 Percentage of Participants |
| DECAVAC® Vaccine Group | Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine. | Diphtheria (N = 1091; 370) | 66 Percentage of Participants |
Primary
Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.
Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL.
Time frame: Day 35 post-vaccination
Population: Seroprotection was assessed in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADACEL® Vaccine Group | Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®. | Tetanus (N = 1075; 368) | 98 Percentage of Participants |
| ADACEL® Vaccine Group | Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®. | Diphtheria (N = 1093; 371) | 77 Percentage of Participants |
| DECAVAC® Vaccine Group | Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®. | Tetanus (N = 1075; 368) | 98 Percentage of Participants |
| DECAVAC® Vaccine Group | Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®. | Diphtheria (N = 1093; 371) | 79 Percentage of Participants |
Other Pre-specified
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise.
Time frame: Day 0 up to 14 days post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Solicited Injection Site Reaction | 615 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any injection site Pain | 496 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 injection site Pain (Incapacitating) | 6 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any injection site Erythema | 280 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 injection site Erythema (≥ 3.5 cm) | 52 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any injection site Swelling | 209 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 injection site Swelling (≥ 3.5 cm) | 40 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Solicited Systemic Reaction | 420 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Fever | 6 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 Fever (≥ 39.5ºC or ≥ 103.1ºF) | 1 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Headache | 209 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 Headache (Incapacitating) | 7 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Myalgia | 327 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 Myalgia (Incapacitating) | 17 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Malaise | 198 Participants |
| ADACEL® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 Malaise (Incapacitating) | 13 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 Malaise (Incapacitating) | 6 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Solicited Injection Site Reaction | 200 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Fever | 2 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any injection site Pain | 163 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Myalgia | 108 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 injection site Pain (Incapacitating) | 1 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 Fever (≥ 39.5ºC or ≥ 103.1ºF) | 0 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any injection site Erythema | 86 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Malaise | 63 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 injection site Erythema (≥ 3.5 cm) | 19 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Headache | 76 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any injection site Swelling | 59 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 Myalgia (Incapacitating) | 6 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 injection site Swelling (≥ 3.5 cm) | 17 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Grade 3 Headache (Incapacitating) | 4 Participants |
| DECAVAC® Vaccine Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine. | Any Solicited Systemic Reaction | 155 Participants |