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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00631995 |
This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.
Primary Objectives: Safety and Immunogenicity:
To describe the safety and immunogenicity profiles of:
Condition | Intervention | Phase |
Meningitis Meningococcal Infection |
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate Dietary Supplement: Meningococcal polysaccharide group C conjugated |
Phase I |
MedlinePlus related topics: | Meningitis Tetanus |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in Toddlers |
Estimated Enrollment: | 360 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
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2: Experimental |
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
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3: Experimental |
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
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4: Experimental |
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
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5: Experimental |
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular
|
6: Active Comparator |
Dietary Supplement: Meningococcal polysaccharide group C conjugated
0.5 mL, Intramuscular
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The study is designed to evaluate the safety profile and the immunogenicity response after a single dose of TetraMen-T in toddlers.
Ages Eligible for Study: | 12 Months to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Australia | |||||
Melbourne, Australia | |||||
Westmead, Australia | |||||
North Adelaide, Australia | |||||
Herston, Australia | |||||
Perth, Australia |
Sanofi-Aventis |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Related Info 
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Related Info 
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Responsible Party: | Sanofi Pasteur Inc ( Medical Monitor ) |
Study ID Numbers: | MET32 |
First Received: | February 29, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00631995 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
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