study of tetanus and diphtheria toxoids adsorbed combined with component pertussis vaccine and inactivated poliomyelitis

Conditions: Pertussis; Tetanus; Diphtheria; Poliomyelitis; Hepatitis B

Summary: primary objective: * to determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (tdcp-ipv) compared to tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (tdcp-ipv) and hepatitis b vaccine administered concurrently in adolescents 11-14 years of age. secondary objective: * to determine whether concurrent administration of tdcp-ipv and hepatitis b vaccines at 11-14 years of age results in detectable immunologic interactions between components of the two vaccines.

participants will be randomized into one of 2 groups to receive either a dose of the tdcp-ipv on day 0 (visit 1) and hepatitis b vaccine on subsequent visits 2, 3 and 4 (group 1); or no vaccination on day 0, concomitant administration of tdcp-ipv and hepatitis b vaccine on day 28 (visit 2) and hepatitis b vaccine on subsequent visits 3 and 4 (group 2). all participants will be followed up for immunogenicity and safety

Eligibility criteria:
inclusion criteria: * age 11 years and \< 14 years of age. * signed, witnessed and dated informed consent that is obtained prior to the first study intervention. * judged to be in good health on the basis of reported medical history. * plans to remain in the study area for the length of the trial. * all minors have a parent or legal guardian who can read, write and understand english or french. * pregnancy test to be performed on all female participants at the time of enrollment into the study (prior to day of first immunization visit). exclusion criteria: * pregnancy. * known or suspected primary disease of the immune system \[conditions suspected of having an immunologic component such as autoimmune diseases (rheumatoid arthritis or inflammatory bowel disease) will not be excluded unless they meet exclusion criterion 3 or are sufficiently clinically active to meet exclusion criterion 5\]. * malignancy or is receiving immunosuppressive therapy (e.g., daily systemic prednisone ≥ 1 mg/kg would be excluded, participants who are taking topical and inhaled steroids could be included in the study as could participants on a "short course" of oral steroids, 5-7 days, as long as there are not two courses within the previous two week period). * prior receipt of any pertussis, diphtheria, tetanus or polio containing vaccines, including hepatitis b vaccine, within the past 5 years. * any significant underlying chronic disease, including malignancy, cardiopulmonary disease, renal or hepatic dysfunction. * known impairment of neurologic function or seizure disorder of any etiology. * personal history of physician diagnosed or laboratory confirmed pertussis disease within the last 2 years. * receipt of blood products or immunoglobulin within the previous 3 months. * known or suspected allergy to any of the vaccines intended for use in the study or any of the vaccine components including neomycin, streptomycin and polymyxin b. * receipt of any vaccine within 2 weeks of receiving a study vaccine. * daily use of non-steroidal anti-inflammatory drugs.

Keywords: pertussis tetanus diphtheria poliomyelitis hepatitis b acellular pertussis vaccines