Diphtheria, Pertussis, Tetanus
Conditions
Keywords
Pertussis, Tetanus, Diphtheria, Acellular pertussis, ADACEL®,, Tdap vaccine
Brief summary
The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus. Primary Objective: * To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.
Detailed description
This is an open-label, multicenter study to describe the immunological response and safety of repeat administration of an adolescent/adult-formulation tetanus-diphtheria-acellular pertussis Tdap vaccine (ADACEL®), 10 years following initial administration of Tdap vaccine.
Interventions
BIOLOGICALTetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
0.5 ml, IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Received Tdap or Tdap-IPV vaccine in study TD9707 or TD9805. * Never previously received Tdap vaccine and has not received any tetanus-, diphtheria , or pertussis-containing vaccine in the past 10 years. * Participated in TD9707 or TD9805 but does not meet inclusion/
Exclusion criteria
or willing to undergo phlebotomy but not willing to receive Tdap (ADACEL®) vaccine. * Signed Institutional Review Board (IRB)-approved informed consent form * Able to attend all scheduled visits and to comply with all trial procedures * For a woman, a negative urine pregnancy test and the use of effective method(s) of contraception, or the inability to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Day 0 (pre-vaccination) and 30 post-vaccination | Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL. |
| Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Day 30 post-vaccination | Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Day 0 (pre-vaccination) and Day 30 post-vaccination | Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). |
| Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose | Day 30 post-vaccination | Anti-diphtheria or anti-tetanus booster responses were defined as: Pre-vaccination antibody concentrations of \< 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to \< 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response. |
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Day 0 up to Day 7 post-vaccination | Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: \> 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities. |
| Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Day 0 (pre-vaccination) and Day 30 post-vaccination | Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA). |
| Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose | Day 30 post-vaccination | Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration: * ≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was \< LLOQ; or * ≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but \< 4 x LLOQ; or * ≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ. |
Countries
Canada
Participant flow
Recruitment details
Participants were enrolled from 26 June 2008 to 27 February 2009 at 7 medical centers in Canada.
Pre-assignment details
A total of 769 participants who met the inclusion and exclusion criteria were enrolled, 768 were vaccinated and evaluated.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Previous Tdap or Tdap-IPV Recipients Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805) | 361 |
| Group 2: Tdap Vaccine-naïve Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose. | 407 |
| Total | 768 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 2 |
| Overall Study | Protocol Violation | 3 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Group 2: Tdap Vaccine-naïve | Group 1: Previous Tdap or Tdap-IPV Recipients | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 402 Participants | 356 Participants | 758 Participants |
| Age, Continuous | 34.6 Years STANDARD_DEVIATION 12.5 | 31.2 Years STANDARD_DEVIATION 14 | 33.0 Years STANDARD_DEVIATION 13.4 |
| Region of Enrollment Canada | 407 participants | 361 participants | 768 participants |
| Sex: Female, Male Female | 264 Participants | 194 Participants | 458 Participants |
| Sex: Female, Male Male | 143 Participants | 167 Participants | 310 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 309 / 361 | 341 / 407 |
| serious Total, serious adverse events | 3 / 361 | 1 / 407 |
Outcome results
Primary
Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose
Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 30 post-vaccination
Population: Geometric mean concentrations were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Previous Tdap or Tdap-IPV Recipients | Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertussis Toxoid [n=318, 357] | 116 EU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Filamentous Haemagglutinin [n=324, 380] | 214 EU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertactin [n=324, 381] | 266 EU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Fimbriae Types 2 and 3 [n=324, 378] | 779 EU/mL |
| Group 2: Tdap Vaccine-naïve | Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Fimbriae Types 2 and 3 [n=324, 378] | 1015 EU/mL |
| Group 2: Tdap Vaccine-naïve | Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertussis Toxoid [n=318, 357] | 89.2 EU/mL |
| Group 2: Tdap Vaccine-naïve | Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertactin [n=324, 381] | 216 EU/mL |
| Group 2: Tdap Vaccine-naïve | Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose | Filamentous Haemagglutinin [n=324, 380] | 249 EU/mL |
Primary
Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose
Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL.
Time frame: Day 0 (pre-vaccination) and 30 post-vaccination
Population: Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Previous Tdap or Tdap-IPV Recipients | Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-tetanus Pre-vaccination | 45 Percentage of Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-tetanus Post-vaccination | 100 Percentage of Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-Diphtheria Pre-vaccination | 74 Percentage of Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-Diphtheria Post-vaccination | 99 Percentage of Participants |
| Group 2: Tdap Vaccine-naïve | Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-Diphtheria Post-vaccination | 96 Percentage of Participants |
| Group 2: Tdap Vaccine-naïve | Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-tetanus Pre-vaccination | 49 Percentage of Participants |
| Group 2: Tdap Vaccine-naïve | Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-Diphtheria Pre-vaccination | 66 Percentage of Participants |
| Group 2: Tdap Vaccine-naïve | Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-tetanus Post-vaccination | 100 Percentage of Participants |
Other Pre-specified
Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination
Population: Geometric mean concentrations were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertussis Toxoid [Pre, N = 291, 353] | 15.1 EU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertussis Toxoid [Post, N = 318, 357] | 116 EU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Filamentous Haemagglutinin [Pre, N = 324, 380] | 34.8 EU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Filamentous Haemagglutinin [Post, N = 324, 380] | 214 EU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertactin [Pre, N = 324, 381] | 28.2 EU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertactin [Post, N = 324, 381] | 266 EU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Fimbriae Types 2 and 3 [Pre, N = 324, 374] | 124 EU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Fimbriae Types 2 and 3 [Post, N=324, 378] | 779 EU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Fimbriae Types 2 and 3 [Post, N=324, 378] | 1015 EU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertussis Toxoid [Pre, N = 291, 353] | 9.42 EU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertactin [Pre, N = 324, 381] | 8.54 EU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertussis Toxoid [Post, N = 318, 357] | 89.2 EU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Fimbriae Types 2 and 3 [Pre, N = 324, 374] | 37.8 EU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Filamentous Haemagglutinin [Pre, N = 324, 380] | 20.0 EU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Pertactin [Post, N = 324, 381] | 216 EU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Filamentous Haemagglutinin [Post, N = 324, 380] | 249 EU/mL |
Other Pre-specified
Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose
Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination
Population: Geometric mean concentrations were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Anti-Tetanus [Pre, N = 324, 379] | 0.835 IU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Anti-Tetanus [Post, N = 324, 381] | 8.79 IU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Anti-Diphtheria [Pre, N = 324, 381] | 0.283 IU/mL |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Anti-Diphtheria [Post, N = 324, 381] | 4.06 IU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Anti-Diphtheria [Post, N = 324, 381] | 2.74 IU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Anti-Tetanus [Pre, N = 324, 379] | 0.778 IU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Anti-Diphtheria [Pre, N = 324, 381] | 0.198 IU/mL |
| Group 2: Tdap Vaccine-naïve | Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose | Anti-Tetanus [Post, N = 324, 381] | 9.64 IU/mL |
Other Pre-specified
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose
Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: \> 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities.
Time frame: Day 0 up to Day 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) |
|---|---|---|---|
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Pain [N = 352, 404] | 309 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Pain [N = 352, 404] | 9 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Erythema [N = 351, 404] | 81 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Erythema [N = 351, 404] | 7 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Swelling [N= 352, 403] | 72 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Swelling [N= 352, 403] | 9 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Fever [N = 356, 405] | 15 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Fever [N = 356, 405] | 0 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Headache [N = 350, 404] | 142 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Headache [N = 350, 404] | 6 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Malaise [N = 350, 404] | 103 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Malaise [N = 350, 404] | 7 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Myalgia [N = 351, 404] | 211 Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Myalgia [N = 351, 404] | 8 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Malaise [N = 350, 404] | 117 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Pain [N = 352, 404] | 341 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Fever [N = 356, 405] | 0 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Pain [N = 352, 404] | 7 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Myalgia [N = 351, 404] | 216 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Erythema [N = 351, 404] | 120 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Headache [N = 350, 404] | 152 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Erythema [N = 351, 404] | 7 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Malaise [N = 350, 404] | 8 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Swelling [N= 352, 403] | 94 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Headache [N = 350, 404] | 8 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Swelling [N= 352, 403] | 7 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Grade 3 Myalgia [N = 351, 404] | 6 Participants |
| Group 2: Tdap Vaccine-naïve | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose | Any Fever [N = 356, 405] | 20 Participants |
Other Pre-specified
Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose
Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration: * ≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was \< LLOQ; or * ≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but \< 4 x LLOQ; or * ≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ.
Time frame: Day 30 post-vaccination
Population: Booster response for each anti-Pertussis antibody was assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Previous Tdap or Tdap-IPV Recipients | Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-Pertussis Toxoid [N = 285, 330] | 88 Percentage of Particpants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose | Filamentous Haemagglutinin [N = 324, 379] | 88 Percentage of Particpants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose | Pertactin [N = 324, 381] | 90 Percentage of Particpants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose | Fimbriae Types 2 and 3 [N = 324, 371] | 84 Percentage of Particpants |
| Group 2: Tdap Vaccine-naïve | Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose | Fimbriae Types 2 and 3 [N = 324, 371] | 93 Percentage of Particpants |
| Group 2: Tdap Vaccine-naïve | Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-Pertussis Toxoid [N = 285, 330] | 84 Percentage of Particpants |
| Group 2: Tdap Vaccine-naïve | Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose | Pertactin [N = 324, 381] | 93 Percentage of Particpants |
| Group 2: Tdap Vaccine-naïve | Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose | Filamentous Haemagglutinin [N = 324, 379] | 94 Percentage of Particpants |
Other Pre-specified
Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose
Anti-diphtheria or anti-tetanus booster responses were defined as: Pre-vaccination antibody concentrations of \< 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to \< 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response.
Time frame: Day 30 post-vaccination
Population: Booster Response to Tetanus and Diptheria antigens were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Previous Tdap or Tdap-IPV Recipients | Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-Tetanus [N = 324, 379] | 83 Percentage of Participants |
| Group 1: Previous Tdap or Tdap-IPV Recipients | Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-Diphtheria [N = 324, 381] | 86 Percentage of Participants |
| Group 2: Tdap Vaccine-naïve | Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-Tetanus [N = 324, 379] | 82 Percentage of Participants |
| Group 2: Tdap Vaccine-naïve | Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose | Anti-Diphtheria [N = 324, 381] | 81 Percentage of Participants |