Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis

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.