Diphtheria, Pertussis, Tetanus
Conditions
Keywords
Tetanus, diphtheria, acellular pertussis
Brief summary
This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
Interventions
BIOLOGICALADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
0.5 mL, IM
BIOLOGICALBOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis 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
11 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 11 - 18 years of age at the time of vaccination in this trial * Signed Institutional Review Board (IRB)-approved informed assent / consent form. * Able to attend all scheduled visits and to comply with all trial procedures. * For a female, negative serum/urine pregnancy test.
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 (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc) that is unstable or that 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. * Febrile illness within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38°C) at the time of inclusion. * History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years. * Known or suspected receipt of a tetanus or diphtheria-containing vaccine within the preceding 2 years. * Known or suspected receipt of a pertussis-containing vaccine within the preceding 5 years. * Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other therapy expected to materially alter immune function within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. * Received any vaccine in the 21-day period prior to enrollment or scheduled to receive any vaccination after enrollment and prior to visit 2. * Suspected or known hypersensitivity to any of the vaccine components or to latex.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Day 0 to 7 post-vaccination | Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities. |
| Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Day 0 and 28 days post-vaccination | — |
| Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Day 0 and 28 days post-vaccination | — |
| Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Day 0 and 28 days post-vaccination | — |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 09 May 2006 to 02 October 2006 in 12 clinical centers in the US.
Pre-assignment details
A total of 647 participants who met the inclusion and exclusion criteria were enrolled, 644 were vaccinated and included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Adacel® Vaccine Group | 323 |
| Boostrix® Vaccine Group | 321 |
| Total | 644 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Boostrix® Vaccine Group | Adacel® Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 291 Participants | 291 Participants | 582 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 32 Participants | 62 Participants |
| Age Continuous | 14.7 years STANDARD_DEVIATION 2.33 | 14.5 years STANDARD_DEVIATION 2.33 | 14.6 years STANDARD_DEVIATION 2.33 |
| Region of Enrollment United States | 321 participants | 323 participants | 644 participants |
| Sex: Female, Male Female | 150 Participants | 154 Participants | 304 Participants |
| Sex: Female, Male Male | 171 Participants | 169 Participants | 340 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 273 / 320 | 257 / 317 |
| serious Total, serious adverse events | 0 / 323 | 0 / 321 |
Outcome results
Primary
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time frame: Day 0 and 28 days post-vaccination
Population: Geometric mean concentration of antibody to the pertussis antigens were analyzed in the per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adacel® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-pertussis toxoid IgG: pre-vaccination | 14.4 EU/mL |
| Adacel® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-filamentous hemagglutinin IgG:pre-vaccination | 26.1 EU/mL |
| Adacel® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-pertactin IgG: pre-vaccination | 12.4 EU/mL |
| Adacel® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-fimbriae types 2 and 3 IgG: pre-vaccination | 13.9 EU/mL |
| Adacel® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-pertussis toxoid IgG: post-vaccination | 86.7 EU/mL |
| Adacel® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-filamentous hemagglutinin IgG post-vaccinat. | 240.7 EU/mL |
| Adacel® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-pertactin IgG: post-vaccination | 322.7 EU/mL |
| Adacel® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-fimbriae types 2 and 3 IgG: post-vaccination | 1203 EU/mL |
| Boostrix® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-fimbriae types 2 and 3 IgG: post-vaccination | 26.6 EU/mL |
| Boostrix® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-pertussis toxoid IgG: pre-vaccination | 13.5 EU/mL |
| Boostrix® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-pertussis toxoid IgG: post-vaccination | 135.9 EU/mL |
| Boostrix® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-filamentous hemagglutinin IgG:pre-vaccination | 28.2 EU/mL |
| Boostrix® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-pertactin IgG: post-vaccination | 463.3 EU/mL |
| Boostrix® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-pertactin IgG: pre-vaccination | 13.1 EU/mL |
| Boostrix® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-filamentous hemagglutinin IgG post-vaccinat. | 402.9 EU/mL |
| Boostrix® Vaccine Group | Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®. | Anti-fimbriae types 2 and 3 IgG: pre-vaccination | 14.5 EU/mL |
Primary
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®
Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities.
Time frame: Day 0 to 7 post-vaccination
Population: Solicited injection site and Systemic reactions were analyzed in the intent-to-treat safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Gr 3 solicited Headache: Prevents daily activities | 3 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited Malaise | 91 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Gr 3 solicited Malaise: Prevents daily activities | 8 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited Myalgia | 167 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Gr 3 solicited Myalgia: Prevents daily activities | 1 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited injection site reaction | 273 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited injection site reaction | 5 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited injection site Pain | 270 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited inj. site Pain (Incapacitating) | 2 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited injection site Erythema | 75 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited injection site Erythema (≥ 5 cm) | 2 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited injection site Swelling | 61 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited injection site Swelling (≥ 5 cm) | 2 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited systemic reaction | 216 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited systemic reaction | 9 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited Fever | 18 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited Fever (≥ 39.1°C or ≥ 102.3°F) | 1 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited Headache | 136 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited systemic reaction | 205 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Gr 3 solicited Headache: Prevents daily activities | 4 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited injection site Erythema | 67 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited Malaise | 78 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited Headache | 108 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Gr 3 solicited Malaise: Prevents daily activities | 6 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited injection site Erythema (≥ 5 cm) | 1 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited Myalgia | 166 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited systemic reaction | 9 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Gr 3 solicited Myalgia: Prevents daily activities | 3 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited injection site Swelling | 44 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited injection site reaction | 257 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited Fever (≥ 39.1°C or ≥ 102.3°F) | 0 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited injection site reaction | 4 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited injection site Swelling (≥ 5 cm) | 1 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited injection site Pain | 247 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Any solicited Fever | 9 Participants |
| Boostrix® Vaccine Group | Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix® | Grade 3 solicited inj. site Pain (Incapacitating) | 3 Participants |
Primary
Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time frame: Day 0 and 28 days post-vaccination
Population: Diphtheria antitoxin concentrations were analyzed in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adacel® Vaccine Group | Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Diphtheria IgG antitoxin ≥0.1 IU/mL : pre-vacc | 92 Percentage of Participants |
| Adacel® Vaccine Group | Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Diphtheria IgG antitoxin ≥0.1 IU/mL: 28 D post-vac | 100 Percentage of Participants |
| Boostrix® Vaccine Group | Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Diphtheria IgG antitoxin ≥0.1 IU/mL : pre-vacc | 93 Percentage of Participants |
| Boostrix® Vaccine Group | Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Diphtheria IgG antitoxin ≥0.1 IU/mL: 28 D post-vac | 100 Percentage of Participants |
Primary
Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time frame: Day 0 and 28 days post-vaccination
Population: Tetanus antitoxin concentrations were analyzed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adacel® Vaccine Group | Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Tetanus IgG antitoxin ≥0.1 IU/mL :pre-vaccination | 99 Percentage of Participants |
| Adacel® Vaccine Group | Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Tetanus IgG antitoxin ≥0.1 IU/mL :28 days post-vac | 100 Percentage of Participants |
| Boostrix® Vaccine Group | Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Tetanus IgG antitoxin ≥0.1 IU/mL :pre-vaccination | 98 Percentage of Participants |
| Boostrix® Vaccine Group | Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®. | Tetanus IgG antitoxin ≥0.1 IU/mL :28 days post-vac | 100 Percentage of Participants |