study of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (adacel®) as a booster in adolescents

Conditions: Pertussis; Tetanus; Diphtheria

Summary: 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.

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.

Eligibility criteria:
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.

Keywords: pertussis tetanus diphtheria acellular pertussis adacel® tdap vaccine