An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster (Tdap Booster)

Inclusion Criteria:

• healthy subject
• 14-15 years old
• eligible for their school-leaving booster for DTP
• received a complete primary vaccination with a 5-component acellular pertussis vaccine (DT5aP-IPV-Hib) at 3, 5 and 12 months of age and vaccinated with a 5-component acellular pertussis vaccine (Td5aP-IPV or Td5aP + IPV) as a booster at 5½ years of age
• informed consent form signed by the subject and parent(s)/legal representative
• subject understand and comply with the study procedures (i.e. able to read and write Swedish)
• female must provide an agreement that they are either sexually continent or practice adequate contraceptive methods (intra-uterine contraceptive device (IUCD), hormonal contraceptives, condoms or other adequate barrier contraception).

Exclusion Criteria:

• acute febrile illness or axillary temperature ≥38.0°C at the time of vaccination
• receipt of immunoglobulin within the previous 3 months, immunosuppression (e g evidence of impaired cell mediated immunity, receipt of immunosuppressant drugs within the previous 3 months or receipt of systemic corticosteroids given daily or on alternate days at ≥20 mg/day prednisone equivalent during >14 days within the past 30 days)
• receipt of a non-study vaccine in the past 30 days
• evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine
• booster vaccination with tetanus, low dose diphtheria and acellular pertussis vaccine since the booster vaccination at 5½ years of age
• previous clinical or bacteriological diagnosis of diphtheria, tetanus or pertussis
• hypersensitivity to any component of any of the study vaccines
• current participation in any other clinical trial or participation in any clinical trial in the previous month
• inability to adhere to the protocol, including plans to move from the area
• severe chronic disease
• family history of congenital or hereditary immunodeficiency
• any sever thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
• any medical condition, which in the opinion of the investigator, might interfere with the evaluation of the study objectives.