Status:
COMPLETED
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
Lead Sponsor:
Sanofi
Conditions:
Meningococcal Meningitis
Tetanus
Eligibility:
All Genders
4-7 years
Phase:
PHASE2
Brief Summary
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 eval...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
882 Patients enrolled
Trial Details
Trial ID
NCT00355121
Start Date
October 1 2006
End Date
July 1 2009
Last Update
August 24 2011
Active Locations (26)
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1
Little Rock, Arkansas, United States, 72205
2
Boulder, Colorado, United States, 80304
3
Atlanta, Georgia, United States, 30322
4
Layton, UT 84041, Georgia, United States, 30062