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

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.

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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
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®




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.



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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.

Information from the National Library of Medicine

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


Locations
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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
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Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00643916     History of Changes
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

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis; Meningococcal Infection

Additional relevant MeSH terms:
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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