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

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

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.