Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects

All subjects will receive a single dose of vaccine, and will be assessed for immunogenicity
at baseline (pre-vaccination) and at 30 days post-vaccination. They will also be monitored
for safety from day of vaccination up to Day 180 post-vaccination.

Inclusion Criteria:

- Aged 10 to 18 years, 19 to 64 years, or ≥ 65 years on the day of inclusion

- Informed consent form has been signed and dated by the subject, or assent form has
been signed and dated by the subject and informed consent form has been signed and
dated by the parent/guardian

- Subject or subject and parent/guardian able to attend all scheduled visits and to
comply with all study procedures.

Exclusion Criteria:

- Subject is pregnant, or lactating, or of childbearing potential, (to be considered of
non-childbearing potential, a female must be premenarche or post-menopausal for at
least 1 year) surgically sterile, or using an effective method of contraception or
abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after
vaccination

- Participation at the time of study enrollment or planned participation during the
present study period in another clinical trial investigating a vaccine, drug, medical
device, or medical procedure

- Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt
of any vaccine between Visit 1 and Visit 2

- Known or suspected receipt of a tetanus toxoid, reduced diphtheria toxoid, and
Acellular pertussis (Tdap) vaccine or Tdap-containing vaccine at any point in time, or
receipt of a tetanus and diphtheria containing vaccine in the preceding 5 years

- Receipt of immune globulins, blood or blood-derived products in the past 3 months

- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy
such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months,
or long-term systemic corticosteroids therapy

- History of diphtheria, tetanus, or pertussis infection (confirmed either serologically
or microbiologically)

- Known or suspected systemic hypersensitivity to any of the vaccine components or
history of life-threatening reaction to the study vaccine or a vaccine containing the
same substances

- Laboratory-confirmed / self-reported thrombocytopenia or bleeding disorder
contraindicating intramuscular vaccination

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular vaccination

- History of encephalopathy (e.g., coma, decreased level of consciousness, or prolonged
seizures) not attributable to another identifiable cause within 7 days of
administration of a previous dose of diphtheria and tetanus toxoids and pertussis
(DTP), or diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine

- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily

- Current alcohol abuse or drug addiction

- Chronic illness that is at a stage where it might interfere with trial conduct or
completion

- Moderate or severe acute illness/infection on the day of vaccination or febrile
illness (temperature ≥ 100.4°F)

- Identified as an Investigator or employee of the Investigator or study center with
direct involvement in the proposed study, or identified as an immediate family member
(i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
direct involvement in the proposed study.