Diphtheria, Pertussis, Tetanus, Whooping Cough
Conditions
Keywords
Adacel® vaccine, Tetanus, Diphtheria, whooping cough, Pertussis, BOOSTRIX® vaccine
Brief summary
The aim of this study is to describe immunogenicity of a single booster dose of Adacel vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to \<13 years of age. Primary objective: * To describe seroprotection rates against tetanus and diphtheria in subjects randomized to receive either Adacel or Boostrix vaccine. Observational objectives: * To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean antibody concentrations (GMCs) in subjects randomized to receive either Adacel or Boostrix vaccine. * To describe booster response rates against tetanus, diphtheria, and pertussis in subjects randomized to receive either Adacel or Boostrix vaccine. * To describe the rates of adverse events (AEs) immediately post-vaccination, and the rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with Adacel or Boostrix vaccine from Visit 1 through Visit 2.
Detailed description
Participants will be randomized in a 1:1 ratio to receive either Adacel or Boostrix vaccine. Subjects will be monitored for immediate reactions for 15 minutes post-vaccination. Unsolicited adverse events and serious adverse events will be collected from Visit 1 through Visit 2.
Interventions
BIOLOGICALTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
0.5 mL, Intramuscular
BIOLOGICALTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is 11 to \< 13 years of age at the time of vaccination * Received exactly 5 doses of pertussis vaccine at \< 7 years of age * Informed consent and assent forms have been signed and dated * Subject is able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence for at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination * Any condition that, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months) * Known or suspected receipt of any whole-cell pertussis-containing vaccine * A personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the last 2 years * A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of receiving the vaccine * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances * Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the 2nd visit; except that influenza vaccine may have been received between 30 and 15 days (but no less than 15 days) before receiving study vaccine * Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, at the discretion of the Sponsor * Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the subject's parent/guardian * Laboratory-confirmed thrombocytopenia, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for IM vaccination, at the discretion of the Investigator * Personal history of Guillain-Barré syndrome * Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. (A prospective subject should not be enrolled in the study until the condition has resolved or the febrile event has subsided.) * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Day 0 (pre-vaccination) to Day 28 (post-vaccination) | Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Day 0 (pre-vaccination) to Day 28 post-vaccination | Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test |
| Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Day 28 post-vaccination | Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤2.56 IU/mL for diphtheria and ≤2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration \>2.56 IU/mL for diphtheria and \>2.7 IU/mL for tetanus. Boostrix booster response defined as: a post-vaccination titer ≥4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer \< LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ. |
| Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Day 0 (pre-vaccination) to Day 28 post-vaccination | Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2&3) were assayed by Enzyme-linked immunosorbent assay (ELISA) |
| Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Day 28 post-vaccination | Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre vaccination concentration ≤93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤170 EU/mL for Filamentous hemagglutinin (FHA), ≤115 EU mL for pertactin (PRN), or ≤285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration \>93 EU/mL for PT, \>170 EU/mL for FHA, \>115 EU/mL for PRN, or \>285 EU/mL for FIM. Boostrix booster response defined as: a post-vaccination titer ≥4 times the LLOQ for subjects with a pre-vaccination titer \<LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ. |
| Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Up to 15 minutes post-vaccination | The occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA) preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs. |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 20 June 2012 to 10 September 2012 at 8 centers in the United States.
Pre-assignment details
A total of 423 participants that met all of the inclusion and none of the exclusion criteria were randomized, 422 were vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Adacel® Vaccine Group Participants received a single dose of Adacel® vaccine | 212 |
| BOOSTRIX® Vaccine Group Participants received a single dose of BOOSTRIX® vaccine | 211 |
| Total | 423 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive study vaccine | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Protocol Violation | 4 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | BOOSTRIX® Vaccine Group | Adacel® Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 211 Participants | 212 Participants | 423 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 | 11.6 Years STANDARD_DEVIATION 0.5 | 11.6 Years STANDARD_DEVIATION 0.5 | 11.6 Years STANDARD_DEVIATION 0.5 |
| Region of Enrollment United States | 211 Participants | 212 Participants | 423 Participants |
| Sex: Female, Male Female | 106 Participants | 105 Participants | 211 Participants |
| Sex: Female, Male Male | 105 Participants | 107 Participants | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 58 / 211 | 70 / 211 |
| serious Total, serious adverse events | 0 / 211 | 0 / 211 |
Outcome results
Primary
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL
Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Population: The antibody responses to tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adacel® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (pre-vaccination) ≥0.1 IU/mL | 172 Participants |
| Adacel® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (post-vaccination) ≥0.1 IU/mL | 196 Participants |
| Adacel® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (pre-vaccination) ≥0.1 IU/mL | 135 Participants |
| Adacel® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (post-vaccination) ≥ 0.1 IU/mL | 196 Participants |
| Adacel® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (pre-vaccination) ≥ 1.0 IU/mL | 33 Participants |
| Adacel® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (post-vaccination) ≥ 1.0 IU/mL | 195 Participants |
| Adacel® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (pre-vaccination) ≥1.0 IU/mL | 28 Participants |
| Adacel® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (post-vaccination) ≥1.0 IU/mL | 183 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (post-vaccination) ≥1.0 IU/mL | 186 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (pre-vaccination) ≥0.1 IU/mL | 177 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (pre-vaccination) ≥ 1.0 IU/mL | 48 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (post-vaccination) ≥0.1 IU/mL | 194 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (pre-vaccination) ≥1.0 IU/mL | 26 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (pre-vaccination) ≥0.1 IU/mL | 139 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (post-vaccination) ≥ 1.0 IU/mL | 194 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (post-vaccination) ≥ 0.1 IU/mL | 194 Participants |
Secondary
Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test
Time frame: Day 0 (pre-vaccination) to Day 28 post-vaccination
Population: The geometric mean concentrations of tetanus and diphtheria antibodies were determined in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adacel® Vaccine Group | Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (pre-vaccination) | 0.422 Titers |
| Adacel® Vaccine Group | Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (post-vaccination) | 18.9 Titers |
| Adacel® Vaccine Group | Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (pre-vaccination) | 0.211 Titers |
| Adacel® Vaccine Group | Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (post-vaccination) | 8.17 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (post-vaccination) | 5.62 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (pre-vaccination) | 0.456 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria (pre-vaccination) | 0.221 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus (post-vaccination) | 9.18 Titers |
Secondary
Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2&3) were assayed by Enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 0 (pre-vaccination) to Day 28 post-vaccination
Population: Geometric mean concentrations of the Pertussis antibodies were determined in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adacel® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertussis toxoid (pre-vaccination) | 5.59 Titers |
| Adacel® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertactin (pre-vaccination) | 12.3 Titers |
| Adacel® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Filamentous hemagglutinin (pre-vaccination) | 22.7 Titers |
| Adacel® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertactin (post-vaccination) | 263 Titers |
| Adacel® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertussis toxoid (post-vaccination) | 31.0 Titers |
| Adacel® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Fimbriae types 2 and 3 (pre-vaccination) | 5.95 Titers |
| Adacel® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Filamentous hemagglutinin (post-vaccination) | 255 Titers |
| Adacel® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Fimbriae types 2 and 3 (post-vaccination) | 346 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Filamentous hemagglutinin (post-vaccination) | 318 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertussis toxoid (pre-vaccination) | 5.69 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertussis toxoid (post-vaccination) | 44.1 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Filamentous hemagglutinin (pre-vaccination) | 22.7 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Fimbriae types 2 and 3 (post-vaccination) | 11.1 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertactin (pre-vaccination) | 10.3 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertactin (post-vaccination) | 252 Titers |
| BOOSTRIX® Vaccine Group | Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Fimbriae types 2 and 3 (pre-vaccination) | 6.55 Titers |
Secondary
Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
The occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA) preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs.
Time frame: Up to 15 minutes post-vaccination
Population: Number of participants reporting immediate unsolicited adverse events was determined in all participants in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adacel® Vaccine Group | Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Headache | 1 Participants |
| Adacel® Vaccine Group | Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Nausea | 1 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Headache | 0 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Nausea | 0 Participants |
Secondary
Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤2.56 IU/mL for diphtheria and ≤2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration \>2.56 IU/mL for diphtheria and \>2.7 IU/mL for tetanus. Boostrix booster response defined as: a post-vaccination titer ≥4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer \< LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ.
Time frame: Day 28 post-vaccination
Population: Booster response against tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adacel® Vaccine Group | Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus | 194 Participants |
| Adacel® Vaccine Group | Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria | 189 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Tetanus | 191 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Diphtheria | 188 Participants |
Secondary
Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre vaccination concentration ≤93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤170 EU/mL for Filamentous hemagglutinin (FHA), ≤115 EU mL for pertactin (PRN), or ≤285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration \>93 EU/mL for PT, \>170 EU/mL for FHA, \>115 EU/mL for PRN, or \>285 EU/mL for FIM. Boostrix booster response defined as: a post-vaccination titer ≥4 times the LLOQ for subjects with a pre-vaccination titer \<LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ.
Time frame: Day 28 post-vaccination
Population: Booster response against Pertussis antibodies were determined in the Per-Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adacel® Vaccine Group | Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertussis toxoid | 97 Participants |
| Adacel® Vaccine Group | Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Filamentous hemagglutinin | 167 Participants |
| Adacel® Vaccine Group | Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertactin | 186 Participants |
| Adacel® Vaccine Group | Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Fimbriae types 2 and 3 | 181 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Fimbriae types 2 and 3 | 31 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertussis toxoid | 142 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Pertactin | 189 Participants |
| BOOSTRIX® Vaccine Group | Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine | Filamentous hemagglutinin | 189 Participants |