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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00643916

Purpose

The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of TetraMenD administered in children less than 2 years of age.

Primary Objective:

To describe the immunogenicity profile of one or two doses of 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 >=3 to <6 years of age.

Condition	Intervention	Phase
Meningitis Meningococcal Infection	Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine	Phase II

MedlinePlus related topics: Diphtheria Meningitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Immunogenicity: To provide information concerning the immune response of TetraMenD after first and second vaccination [ Time Frame: 28 days after each injection ] [ Designated as safety issue: No ]

Enrollment:	378
Study Start Date:	December 2004
Study Completion Date:	October 2007
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate 0.5 mL, Intramuscular (at age 9 and 12 months)
2: Experimental	Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate 0.5 mL, Intramuscular (at age 9 and 15 months)
3: Experimental	Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate 0.5 mL, Intramuscular (at age 12 and 15 months)
4: Experimental	Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate 0.5 mL, Intramuscular (at age 15 months)
5: Experimental	Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate 0.5 mL, Intramuscular (at age 18 months)
6: Active Comparator	Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine 0.5 mL, Subcutaneous (at >3 to <6 years of age)

Detailed Description:

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

Eligibility

Ages Eligible for Study:	9 Months to 5 Years
Genders Eligible for Study:	Both
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 >= 100.4oF (>= 38.0 oC) or axillary temperature >=99.4 oF (>= 37.4 oC) 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 IM 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643916

Locations

United States, Arkansas

Little Rock, Arkansas, United States, 72205
United States, Connecticut

Norwich, Connecticut, United States, 06360
United States, Georgia

Marietta, Georgia, United States, 30062

Atlanta, Georgia, United States, 30322
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

Sellersville, Pennsylvania, United States, 18960
United States, Tennessee

Kingsport, Tennessee, United States, 37664

Sponsors and Collaborators

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur, Inc ( Medical Monitor )
Study ID Numbers:	MTA26, MTA26
Study First Received:	March 24, 2008
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00643916 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Meningitis; Meningococcal Infection

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Central Nervous System Diseases

Meningococcal Infection
Diphtheria
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Bacterial Infections
Nervous System Diseases
Central Nervous System Diseases
Diphtheria
Infection
Actinomycetales Infections
Meningitis

Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Central Nervous System Infections
Corynebacterium Infections
Meningococcal Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on May 07, 2009