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

Completed · Phase 2

Conditions studied: Meningococcal Meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis

In brief

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.

Key facts

Study ID

NCT00355121

Run by

Sanofi

People needed

882

Starts

2006-10-01

Expected to finish

2009-07-01

Last updated by the study team

2011-08-24

Who can join

Age: 4 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Boulder, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Layton, UT 84041, Georgia, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Woburn, Massachusetts, United States
• Study site — Bridgeton, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Rochester, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Akron, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — University Heights, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Sellersville, Pennsylvania, United States
• Study site — Kingsport, Tennessee, United States
• Study site — Layton, Utah, United States
• Study site — Ogden, Utah, United States
• Study site — Pleasant Grove, Utah, United States
• Study site — Provo, Utah, United States
• Study site — Salt Lake City, Utah, United States
• Study site — South Jordan, Utah, United States
• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.