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

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

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.

Study Overview

• Status: Completed
• 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®)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 378
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
  • Connecticut
    • Norwich, Connecticut, United States, 06360
  • Georgia
    • Atlanta, Georgia, United States, 30322
    • Marietta, Georgia, United States, 30062
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
  • Maryland
    • Baltimore, Maryland, United States, 21201
  • Massachusetts
    • Woburn, Massachusetts, United States, 01801
  • Ohio
    • Akron, Ohio, United States, 44308
    • Columbus, Ohio, United States, 43205
  • Pennsylvania
    • Drexel Hill, Pennsylvania, United States, 19026
    • Pittsburg, Pennsylvania, United States, 15241
    • Sellersville, Pennsylvania, United States, 18960
  • Tennessee
    • Kingsport, Tennessee, United States, 37664
  • Utah
    • Salt Lake City, Utah, United States, 84123

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / 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 Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 9 and 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 12 and 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 18 months); Other Names: 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 12 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 9 and 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 12 and 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 18 months); Other Names: 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 9 and 12 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 9 and 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 12 and 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 18 months); Other Names: 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 9 and 12 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 9 and 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 12 and 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 18 months); Other Names: 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 9 and 12 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 9 and 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 12 and 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 15 months); Other Names: Menactra®; Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); 0.5 mL, Intramuscular (at age 18 months); Other Names: 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 Names: Menomune®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.	Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.	Day 0 up to 7 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: March 24, 2008
• First Submitted That Met QC Criteria: March 25, 2008
• First Posted (Estimate): March 26, 2008

Study Record Updates

• Last Update Posted (Estimate): February 14, 2014
• Last Update Submitted That Met QC Criteria: January 21, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Meningitis; Meningococcal Infection
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Corynebacterium Infections; Neisseriaceae Infections; Diphtheria; Meningitis; Meningococcal Infections
• Other Study ID Numbers: MTA26