Status:
COMPLETED
Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningitis
Meningococcal Infection
Eligibility:
All Genders
9-5 years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary Objective: To ...
Detailed Description
This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged either 9, 12, 15 or 18 months of age or 3 to \< 6 years of age on the day of inclusion.
- Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian
- Able to attend all scheduled visits and to comply with all trial procedures
- Exclusion Criteria :
- History of a serious chronic disease that could interfere with trial conduct or completion.
- Known or suspected impairment of immunologic function.
- Acute medical illness with or without fever within the last 72 hours, or rectal temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the day of inclusion.
- History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination.
- Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
- Antibiotic therapy within the 72 hours prior to having any blood sample drawn.
- Received or scheduled to receive any vaccine in the 28-day period prior to receipt of either dose of the study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 28-day period after receipt of either dose of the study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or after receiving the trial vaccine.
- Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- Unable to attend one or more of the scheduled visits or to comply with the study procedures.
- Participation in another clinical trial in the 4 weeks preceding enrollment.
- Planned participation in another clinical trial during the present trial period.
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT00643916
Start Date
December 1 2004
End Date
October 1 2007
Last Update
February 14 2014
Active Locations (14)
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1
Little Rock, Arkansas, United States, 72205
2
Norwich, Connecticut, United States, 06360
3
Atlanta, Georgia, United States, 30322
4
Marietta, Georgia, United States, 30062