Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
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ClinicalTrials.gov Identifier: NCT00643916 |
Recruitment Status :
Completed
First Posted : March 26, 2008
Results First Posted : January 8, 2010
Last Update Posted : February 14, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Meningitis Meningococcal Infection | Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®) Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 378 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | December 2004 |
Actual Primary Completion Date : | March 2006 |
Actual Study Completion Date : | October 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Vaccinated at Age 9 and 12 Months
Participants received Menactra® vaccine at 9 and 12 Months of age
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Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 9 and 12 months)
Other Name: Menactra® |
Experimental: Vaccinated at Age 9 and 15 Months
Participants received Menactra® vaccine at 9 and 15 Months of age
|
Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 9 and 15 months)
Other Name: Menactra® |
Experimental: Vaccinated at Age 12 and 15 Months
Participants received Menactra® vaccine at Age 12 and 12 Months of age
|
Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 12 and 15 months)
Other Name: Menactra® |
Experimental: Vaccinated at Age 15 Months
Participants received Menactra® vaccine at 15 Months of age
|
Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 15 months)
Other Name: Menactra® |
Experimental: Vaccinated at Age 18 Months
Participants received Menactra® vaccine at 18 Months of age
|
Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 18 months)
Other Name: Menactra® |
Active Comparator: Vaccinated at Age 3 Years to <6 Years
Participants received Menomune® vaccine at Age 3 years to <6 years of age
|
Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
0.5 mL, Subcutaneous (at 3 years to <6 years of age)
Other Name: Menomune® |
- Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. [ Time Frame: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2 ]
- Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. [ Time Frame: Day 0 up to 7 post-vaccination ]Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.

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Ages Eligible for Study: | 9 Months to 5 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643916
United States, Arkansas | |
Little Rock, Arkansas, United States, 72205 | |
United States, Connecticut | |
Norwich, Connecticut, United States, 06360 | |
United States, Georgia | |
Atlanta, Georgia, United States, 30322 | |
Marietta, Georgia, United States, 30062 | |
United States, Kentucky | |
Bardstown, Kentucky, United States, 40004 | |
United States, Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Woburn, Massachusetts, United States, 01801 | |
United States, Ohio | |
Akron, Ohio, United States, 44308 | |
Columbus, Ohio, United States, 43205 | |
United States, Pennsylvania | |
Drexel Hill, Pennsylvania, United States, 19026 | |
Pittsburg, Pennsylvania, United States, 15241 | |
Sellersville, Pennsylvania, United States, 18960 | |
United States, Tennessee | |
Kingsport, Tennessee, United States, 37664 | |
United States, Utah | |
Salt Lake City, Utah, United States, 84123 |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00643916 |
Other Study ID Numbers: |
MTA26 |
First Posted: | March 26, 2008 Key Record Dates |
Results First Posted: | January 8, 2010 |
Last Update Posted: | February 14, 2014 |
Last Verified: | January 2014 |
Meningitis; Meningococcal Infection |
Diphtheria Meningococcal Infections Meningitis Infections Central Nervous System Diseases Nervous System Diseases Corynebacterium Infections |
Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Neisseriaceae Infections Gram-Negative Bacterial Infections |