Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®



Status:Completed
Conditions:Infectious Disease, Infectious Disease, Infectious Disease, Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:4 - 7
Updated:10/14/2017
Start Date:October 2006
End Date:July 2009

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Immunogenicity and Safety of Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

The purpose of this study is to evaluate the immunogenicity and safety of the concomitant
administration of Menactra® vaccine and DAPTACEL® vaccine.

The main objectives are:

Immunogenicity:

To evaluate the antibody responses to both vaccines when Menactra vaccine is given
concomitantly with DAPTACEL® compared to when either vaccine is given alone.

Safety:

To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are
administered concomitantly compared to when each vaccine is given alone.


Inclusion Criteria:

- Healthy, as determined by medical history and physical examination.

- Aged 4 to < 7 years at the time of study vaccination on Day 0.

- Informed consent form that has been approved by the Institutional Review Board (IRB)
and signed/dated by the parent or legal guardian.

- Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular
pertussis (DTaP) series.

Exclusion Criteria:

- Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic,
psychiatric, hematologic)

- Known or suspected impairment of immunologic function

- Acute medical illness with or without fever within the last 72 hours or temperature ≥
100.4°F (≥ 38°C) at the time of enrollment

- History of documented invasive meningococcal disease or previous meningococcal
vaccination

- Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or
4th dose of IPV prior to this study.

- Received either immune globulin or other blood products within the last 3 months; or
received injected or oral corticosteroids, or other immunomodulator therapy, within 6
weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids
lasting < 7 days and individuals (e.g., asthmatics) on a short schedule of oral
steroids lasting 3 to 4 days may be included in the trial as long as they have not
received more than one course within the last 2 weeks prior to enrollment.

- Received oral or injected antibiotic therapy within the 72 hours prior to any blood
draw.

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

- Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.

- Unavailable for the entire study period, or unable to attend the scheduled visits or
to comply with the study procedures.

- Enrolled in another clinical trial.

- Diagnosed with any condition, which, in the opinion of the physician investigator,
would pose a health risk to the subject or interfere with the evaluation of the
vaccine.

- Received any other vaccine 30 days prior to the first study vaccination or scheduled
to receive any vaccination during the course of the study.

- Personal or family history of Guillain-Barré Syndrome (GBS).
We found this trial at
26
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Rochester, NY
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Akron, OH
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649
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Albuquerque, NM
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Atlanta, GA
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Bardstown, KY
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813
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Boulder, CO
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1562
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Bridgeton, MO
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1880
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Cincinnati, OH
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1959
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Columbus, OH
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1994
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Kingsport, TN
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585
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Layton, UT
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Layton, UT 84041, Georgia 30062
587
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Layton, UT 84041, GA
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1463
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Little Rock, AR
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Norfolk, VA
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592
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Ogden, UT
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2119
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Pittsburgh, PA
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553
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Pleasant Grove, UT
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216
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Provo, UT
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570
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Salt Lake City, UT
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Sellersville, Pennsylvania 18960
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557
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South Jordan, UT
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Spokane, WA
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St. Louis, MO
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Syracuse, NY
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University Heights, OH
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2573
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Woburn, MA
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