Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents

Study Overview
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Brief Summary
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This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose in adolescents in Japan. Primary Objective: To assess the immunogenicity of Tdap (SP306) when administered as a single dose in Japanese adolescents Secondary Objective: To assess the safety of Tdap vaccine when administered as a single dose in Japanese adolescents.

Detailed Description
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All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and undergo immunogenicity assessment from blood samples provided prior to, and 28 days post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination.

Official Title
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Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) as a Booster in Japanese Adolescents

Conditions
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Pertussis, Tetanus, Diphtheria

Intervention / Treatment
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* Biological: (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 11 or 12 years on the day of inclusion Informed consent form and assent form signed and dated by the parent(s) / legal representative and the subject respectively Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e, received 4 doses of Japanese-produced tetanus toxoid, diphtheria toxoid and acellular pertussis vaccine absorbed [DTaP vaccine]), confirmed by checking immunization records and have not yet undergone additional adsorbed Diphtheria and Tetanus toxoid (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 Known systemic 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, contraindicating intramuscular (IM) vaccination, or a history of thrombocytopenia Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination 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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0. | Biological: (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis<br>* 0.5 mL, Intramuscular<br>* Other names: Tdap Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® | Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination. | Day 28 post-vaccination | 
| Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® | 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. Tetanus 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 ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL. | Day 28 post-vaccination | 
| Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL® | Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2) | Day 28 post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pertussis, Tetanus, Diphtheria, Acellular pertussis, ADACEL®, Tdap vaccine