Study of Adacel® Vaccine Administered to Persons 10 Years of Age



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:10 - 11
Updated:4/21/2016
Start Date:March 2011
End Date:January 2012

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Safety and Immunogenicity of Adacel® Vaccine Administered to Persons 10 Years of Age

The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced
Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10
years of age.

Primary Objectives:

- To compare pertussis antibody responses induced by Adacel® in persons 10 to <11 years
of age to those induced by Adacel in persons 11 to <12 years of age.

- To compare the booster responses against pertussis antigens induced by Adacel in
persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of
age.

- To compare booster responses against tetanus and diphtheria induced by Adacel in
persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of
age.

Secondary Objective:

- To compare seroprotection rates against tetanus and diphtheria induced by Adacel in
persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of
age.

Study participants will receive a single dose of study vaccine and will then be monitored
for safety from the day of vaccination for up to 30 days post-vaccination.

Inclusion Criteria:

- Age is > 10 to < 12 years of age at the time of vaccination.

- Assent form has been signed and dated by the subject, and informed consent has been
signed and dated by the parent(s) or another legally acceptable representative (and
by an independent witness if required by local regulations).

- Subject and parent/guardian are able to attend all scheduled visits and to comply
with all trial procedures.

- For a female of childbearing potential, abstinence or use of an effective method of
contraception from at least 4 weeks prior to vaccination until at least 4 weeks after
vaccination.

- Documented vaccination history of receiving 5 previous doses of DTaP (combination
diphtheria, tetanus, and acellular pertussis) vaccine (consisting of 3 infant doses
in the first year of life, a 4th dose in the 2nd year of life, and a 5th dose at 4
through 6 years of age).

Exclusion Criteria:

- Any condition which, in the opinion of the Investigator, would pose a health risk to
the participant or interfere with the evaluation of the vaccine.

- Serious, acute, or chronic disease that is unstable or that, in the opinion of the
Investigator, might: (i) interfere with the ability to participate fully in the
study; or (ii) interfere with evaluation of the vaccine.

- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy
within the preceding 6 months; or long-term systemic corticosteroid therapy
(prednisone or equivalent for more than 2 consecutive weeks within the past 3
months).

- Prior receipt of pertussis, diphtheria, or tetanus containing vaccines within the
past 5 years.

- A personal history of physician-diagnosed or laboratory confirmed pertussis disease
within the last 2 years.

- A previous severe reaction to pertussis, diphtheria or tetanus vaccine including
immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of
receiving the vaccine.

- Receipt of blood or blood-derived products in the past 3 months, which might
interfere with the assessment of the immune response.

- History of allergy to egg proteins, latex, or any constituents of the vaccine.

- Suspected or known hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccine used in the trial or to a vaccine containing
any of the same substances.

- Receipt of any vaccine within 30 days before receiving study vaccine, or plans to
receive another vaccine before the 2nd visit; except that influenza vaccine may have
been received between 30 and 15 days (but no less than 15 days) before receiving
study vaccine.

- Participation in another interventional clinical trial investigating a vaccine, drug,
medical device, or medical procedure in the 30 days preceding the first study
vaccination or during the course of the study.

- Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C,
as reported by the parent/guardian.

- Laboratory-confirmed thrombocytopenia, bleeding disorders, or receipt of
anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular
vaccination, at the discretion of the Investigator.

- Known pregnancy, or a positive urine or serum pregnancy test.

- Prior personal history of Guillain-Barré syndrome.

- 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.
We found this trial at
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Crestview Hills, Kentucky 41017
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