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

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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.

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

Detailed Description:

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

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vaccinated at Age 9 and 12 Months; Participants received Menactra® vaccine at 9 and 12 Months of age	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®

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Other Outcome Measures:

1. 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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director; Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info  Related Info 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00643916 History of Changes
• Other Study ID Numbers: MTA26
• First Posted: March 26, 2008
• Results First Posted: January 8, 2010
• Last Update Posted: February 14, 2014
• Last Verified: January 2014

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Meningitis; Meningococcal Infection

Additional relevant MeSH terms:

Meningitis; Diphtheria; Meningococcal Infections; Central Nervous System Diseases; Nervous System Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs