study of a tetravalent meningococcal diphtheria toxoid conjugate vaccine in toddlers 9 to 18 months of age

Conditions: Meningitis; Meningococcal Infection

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 describe the immunogenicity profile of one or two doses of menactra® (tetramend) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of menomune® when administered to children aged 3 years to \<6 years of age.

this is a phase ii, open-label, parallel, exploratory, multi-center study in healthy toddlers.

Eligibility criteria:
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.

Keywords: meningitis; meningococcal infection