Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age

Study Overview
=================
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 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.

Detailed Description
-----------------
This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.

Official Title
-----------------
Safety and Immunogenicity of a Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine (TetraMenD) In Toddlers 9 to 18 Months of Age

Conditions
-----------------
Meningitis, Meningococcal Infection

Intervention / Treatment
-----------------
* Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
* Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
* Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
* Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
* Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
* Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccinated at Age 9 and 12 Months<br>Participants received Menactra® vaccine at 9 and 12 Months of age | Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)<br>* 0.5 mL, Intramuscular (at age 9 and 12 months)<br>* Other names: Menactra®;|
| Experimental: Vaccinated at Age 9 and 15 Months<br>Participants received Menactra® vaccine at 9 and 15 Months of age | Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)<br>* 0.5 mL, Intramuscular (at age 9 and 15 months)<br>* Other names: Menactra®;|
| Experimental: Vaccinated at Age 12 and 15 Months<br>Participants received Menactra® vaccine at Age 12 and 12 Months of age | Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)<br>* 0.5 mL, Intramuscular (at age 12 and 15 months)<br>* Other names: Menactra®;|
| Experimental: Vaccinated at Age 15 Months<br>Participants received Menactra® vaccine at 15 Months of age | Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)<br>* 0.5 mL, Intramuscular (at age 15 months)<br>* Other names: Menactra®;|
| Experimental: Vaccinated at Age 18 Months<br>Participants received Menactra® vaccine at 18 Months of age | Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)<br>* 0.5 mL, Intramuscular (at age 18 months)<br>* Other names: Menactra®;|
| Active Comparator: Vaccinated at Age 3 Years to <6 Years<br>Participants received Menomune® vaccine at Age 3 years to <6 years of age | Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)<br>* 0.5 mL, Subcutaneous (at 3 years to <6 years of age)<br>* Other names: Menomune®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. |  | Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meningitis; Meningococcal Infection