Tetanus, Diphtheria, Pertussis
Conditions
Keywords
Tetanus, Diphtheria, Pertussis, TdaP vaccine, DT vaccine
Brief summary
The aim of the study is to generate additional safety and immunogenicity data to support the registration of the product in Japan. Primary objectives: * To demonstrate the non-inferiority of SP306 versus DT (DT 0.1mL) vaccine in terms of diphtheria and tetanus booster response rate (proportion of subjects with booster responses) and seroprotection rate (percentage of subjects with antitoxin concentrations ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age. * To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in terms of booster response rate (proportion of subjects with booster responses) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age. Secondary objectives: * To further evaluate the immune response of the study vaccines against diphtheria, tetanus and pertussis antigens. * To assess the safety of the study vaccines after one injection in Japanese adolescents 11-12 years of age.
Detailed description
Study participants will receive either a single dose of SP306 vaccine intramuscularly or a dose of DT vaccine subcutaneously. They will be monitored after vaccination for immediate adverse events (AEs) solicited injection site and systemic reactions and unsolicited AEs including serious adverse events throughout the study period, approximately 28 days (+7 days).
Interventions
0.5 mL, intramuscularly.
BIOLOGICALDiphtheria and Tetanus toxoids adsorbed
0.1 mL, Subcutaneously
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 11 or 12 years and considered healthy on the day of inclusion * Informed consent form and assent form signed and dated by the parent(s) / legal representative(s) and the subject respectively * Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e., received 4 doses of Japanese-produced DTaP vaccine), confirmed by checking immunization records and have not yet undergone additional DT vaccination * Able to attend all scheduled visits and to comply with all trial procedures * For female subjects, either pre-menarchal, or post-menarchal with a negative urine pregnancy test.
Exclusion criteria
* Any conditions or diseases which, in the opinion of the Investigator: * would pose a health risk to the subject * or might interfere with the ability to participate fully in the study * or might interfere with evaluation of the vaccine * or would otherwise make participation inappropriate according to the Investigator's clinical judgment * History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically * Suspected or known hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine * Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis * Known or suspected congenital immunodeficiency, or current / previous acquired immunodeficiency, or current / previous receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or current / previous (within the last 6 months) systemic corticosteroid therapy * Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion * Planned participation in another clinical trial during the present trial period * Receipt of blood or blood-derived products in the past 3 months, that might interfere with assessment of the immune response * Receipt of any vaccine within the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before the study vaccine * Planned receipt of any vaccine during the trial period * Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection * At high risk for diphtheria, tetanus or pertussis infection during the trial * Known pregnancy, or a positive urine pregnancy test * Currently breastfeeding a child * Known thrombocytopenia or history of thrombocytopenia * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion * History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures * Identified as an employee of an Investigator, a study center, a study-affiliated vendor, or the Sponsor, with direct or indirect involvement in the proposed study or other studies under the direction of that Investigator or study center; or identified as a spouse or child (whether natural or adopted) of such an employee.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT | Day 28 post-vaccination | Diphtheria booster response was defined as a ≥4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration \>2.56 IU/mL. A tetanus booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration \>2.7 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method |
| Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine | Day 28 post-vaccination | Seroprotection was defined as the proportion of subjects at 28 days post-vaccination with diphtheria and tetanus antitoxin concentration ≥0.1 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method |
| Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine | Day 28 post-vaccination | Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but \< 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2). Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine | Pre-vaccination (Day 0) | Seroprotection was defined as the proportion of participants with pre-vaccination with diphtheria and tetanus antitoxin concentration ≥ 0.1 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method. |
| Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Seroprotection was defined as the proportion of participants with diphtheria and tetanus antitoxin concentration level ≥ 0.01 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method. |
| Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method |
| Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine | Day 28 post-vaccination | Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post-vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but \< 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2). Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method. |
| Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method |
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Day 0 up to Day 7 post-vaccination | Solicited injection-site: Pain, Erythema, Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain Significant, prevents daily activity; Erythema and Swelling \>100 mm. Grade 3 systemic reactions: Fever, \>39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity. |
Countries
Japan
Participant flow
Recruitment details
The study participants were enrolled from 01 March 2014 through 31 May 2014 at 21 clinic centers in Japan.
Pre-assignment details
A total of 533 participants who met all of the inclusion criteria - including having completed childhood vaccination against diphtheria, pertussis and tetanus (i.e., received 4 doses of Japanese-produced DTaP vaccine), and none of the exclusion criteria were randomized and vaccinated in this study.
Participants by arm
| Arm | Count |
|---|---|
| SP306 Group Participants received SP306 vaccine intramuscularly | 356 |
| DT Group Participants received DT vaccine subcutaneously | 178 |
| Total | 534 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | DT Group | SP306 Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 178 Participants | 356 Participants | 534 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 Age Continuous | 11.2 Years STANDARD_DEVIATION 0.4 | 11.2 Years STANDARD_DEVIATION 0.4 | 11.2 Years STANDARD_DEVIATION 0.4 |
| Region of Enrollment Japan | 178 Participants | 356 Participants | 534 Participants |
| Sex: Female, Male Female | 83 Participants | 183 Participants | 266 Participants |
| Sex: Female, Male Male | 95 Participants | 173 Participants | 268 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 356 | 12 / 178 |
| serious Total, serious adverse events | 0 / 356 | 0 / 178 |
Outcome results
Primary
Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT
Diphtheria booster response was defined as a ≥4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration \>2.56 IU/mL. A tetanus booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration \>2.7 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
Time frame: Day 28 post-vaccination
Population: Post-vaccination booster response was determined in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SP306 Group | Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT | Diphtheria Booster Response | 99.7 Percentage of Participants |
| SP306 Group | Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT | Tetanus Booster Response | 100 Percentage of Participants |
| DT Group | Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT | Diphtheria Booster Response | 98.3 Percentage of Participants |
| DT Group | Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT | Tetanus Booster Response | 93.8 Percentage of Participants |
Comparison: Non-inferiority comparison of post-booster response for Diphtheria.95% CI: [-0.31, 4.61]
Comparison: Non-inferiority comparison of post-vaccination booster response for tetanus95% CI: [3.32, 10.84]
Primary
Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine
Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but \< 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2). Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method.
Time frame: Day 28 post-vaccination
Population: Post-vaccination pertussis booster response was determined in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SP306 Group | Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine | Pertussis Toxoid | 39.1 Percentage of Participants |
| SP306 Group | Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine | Filamentous Hemagglutinin | 95.1 Percentage of Participants |
| DT Group | Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine | Pertussis Toxoid | 1.1 Percentage of Participants |
| DT Group | Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine | Filamentous Hemagglutinin | 2.3 Percentage of Participants |
Primary
Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine
Seroprotection was defined as the proportion of subjects at 28 days post-vaccination with diphtheria and tetanus antitoxin concentration ≥0.1 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
Time frame: Day 28 post-vaccination
Population: Seroprotection was assessed in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SP306 Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine | Diphtheria | 100 Percentage of Participants |
| SP306 Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine | Tetanus | 100 Percentage of Participants |
| DT Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine | Diphtheria | 99.4 Percentage of Participants |
| DT Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine | Tetanus | 100 Percentage of Participants |
Comparison: Non-inferiority comparison of Diphtheria post-vaccination seroprotection rates at ≥ 0.1 IU/mL95% CI: [-0.61, 3.15]
Comparison: Non-inferiority comparison of Tetanus post-vaccination seroprotection rates at ≥ 0.1 IU/mL95% CI: [-1.09, 2.14]
Secondary
Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine
Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric Mean Concentration were assessed in the per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SP306 Group | Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Diphtheria (pre-vaccination) | 0.10 Titers |
| SP306 Group | Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Tetanus (pre-vaccination) | 0.25 Titers |
| SP306 Group | Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Diphtheria (post-vaccination) | 8.64 Titers |
| SP306 Group | Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Tetanus (post-vaccination) | 26.15 Titers |
| DT Group | Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Diphtheria (post-vaccination) | 10.08 Titers |
| DT Group | Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Diphtheria (pre-vaccination) | 0.10 Titers |
| DT Group | Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Tetanus (post-vaccination) | 7.58 Titers |
| DT Group | Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Tetanus (pre-vaccination) | 0.24 Titers |
Secondary
Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine
Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric Mean Concentration was assessed in the per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SP306 Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Pertussis toxoid (post-vaccination) | 23.83 Titers |
| SP306 Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Pertactin (pre-vaccination) | 7.02 Titers |
| SP306 Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Filamentous Hemagglutinin (pre-vaccination) | 19.14 Titers |
| SP306 Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Filamentous Hemagglutinin (post-vaccination) | 160.66 Titers |
| SP306 Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Fimbriae (post-vaccination) | 233.01 Titers |
| SP306 Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Fimbriae (pre-vaccination) | 3.43 Titers |
| SP306 Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Pertussis toxoid (pre-vaccination) | 6.27 Titers |
| SP306 Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Pertactin (post-vaccination) | 129.59 Titers |
| DT Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Fimbriae (post-vaccination) | 3.63 Titers |
| DT Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Pertactin (pre-vaccination) | 8.20 Titers |
| DT Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Pertactin (post-vaccination) | 7.94 Titers |
| DT Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Pertussis toxoid (pre-vaccination) | 6.15 Titers |
| DT Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Pertussis toxoid (post-vaccination) | 6.07 Titers |
| DT Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Filamentous Hemagglutinin (post-vaccination) | 21.16 Titers |
| DT Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Fimbriae (pre-vaccination) | 3.68 Titers |
| DT Group | Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine | Filamentous Hemagglutinin (pre-vaccination) | 21.55 Titers |
Secondary
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine
Solicited injection-site: Pain, Erythema, Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain Significant, prevents daily activity; Erythema and Swelling \>100 mm. Grade 3 systemic reactions: Fever, \>39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection-site reactions and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Injection-site Erythema | 20.2 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Malaise | 23.9 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Injection-site Erythema | 1.4 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Myalgia | 0.3 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Injection-site Swelling | 20.2 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Injection-site Pain | 0 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Injection-site Swelling | 1.4 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Any solicited systemic reaction | 60.7 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Any Injection-site reaction | 83.1 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Solicited systemic reaction | 0.8 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Injection-site reaction | 2.2 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Malaise | 0.3 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Fever | 0.6 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Injection-site Pain | 80.1 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Headache | 20.5 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Fever | 9.3 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Headache | 0.3 Percentage of Participants |
| SP306 Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Myalgia | 44.1 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Headache | 0 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Injection-site Swelling | 0 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Malaise | 13.5 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Malaise | 0 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Myalgia | 20.2 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Myalgia | 0 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Injection-site reaction | 0 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Injection-site Pain | 48.3 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Injection-site Pain | 0 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Injection-site Erythema | 27.5 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Injection-site Erythema | 0 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Injection-site Swelling | 22.5 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Any solicited systemic reaction | 32.0 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Solicited systemic reaction | 0 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Fever | 2.2 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Grade 3 Fever | 0 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Headache | 12.4 Percentage of Participants |
| DT Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine | Any Injection-site reaction | 64.0 Percentage of Participants |
Secondary
Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine
Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post-vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but \< 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2). Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method.
Time frame: Day 28 post-vaccination
Population: Post-vaccination pertussis booster response was determined in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SP306 Group | Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine | Pertactin | 90.3 Percentage of Participants |
| SP306 Group | Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine | Fimbriae Types 2 and 3 | 94.6 Percentage of Participants |
| DT Group | Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine | Pertactin | 0.6 Percentage of Participants |
| DT Group | Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine | Fimbriae Types 2 and 3 | 0.6 Percentage of Participants |
Secondary
Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine
Seroprotection was defined as the proportion of participants with diphtheria and tetanus antitoxin concentration level ≥ 0.01 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Seroprotection was assessed in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SP306 Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine | Diphtheria (Pre-vaccination) | 97.4 Percentage of Participants |
| SP306 Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine | Diphtheria (Post-vaccination) | 100 Percentage of Participants |
| SP306 Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine | Tetanus (Pre-vaccination) | 100 Percentage of Participants |
| SP306 Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine | Tetanus (Post-vaccination) | 100 Percentage of Participants |
| DT Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine | Tetanus (Post-vaccination) | 100 Percentage of Participants |
| DT Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine | Diphtheria (Pre-vaccination) | 97.7 Percentage of Participants |
| DT Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine | Tetanus (Pre-vaccination) | 99.4 Percentage of Participants |
| DT Group | Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine | Diphtheria (Post-vaccination) | 99.4 Percentage of Participants |
Secondary
Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine
Seroprotection was defined as the proportion of participants with pre-vaccination with diphtheria and tetanus antitoxin concentration ≥ 0.1 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method.
Time frame: Pre-vaccination (Day 0)
Population: Seroprotection was assessed in the per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SP306 Group | Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine | Diphtheria | 46.6 Percentage of Participants |
| SP306 Group | Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine | Tetanus | 77.1 Percentage of Participants |
| DT Group | Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine | Diphtheria | 46.6 Percentage of Participants |
| DT Group | Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine | Tetanus | 77.8 Percentage of Participants |