Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers
Phase 1
Completed
- Conditions
- MeningitisMeningococcal Infection
- Interventions
- Biological: Meningococcal Polysaccharide Tetanus Protein ConjugateDietary Supplement: Meningococcal polysaccharide group C conjugated
- Registration Number
- NCT00631995
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
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:
* A single dose of each formulation of TetraMen-T vaccine
* A single dose of NeisVac-C® vaccine.
- Detailed Description
The study is designed to evaluate the safety profile and the immunogenicity response after a single dose of TetraMen-T in toddlers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 4 Meningococcal Polysaccharide Tetanus Protein Conjugate - Group 2 Meningococcal Polysaccharide Tetanus Protein Conjugate - Group 5 Meningococcal Polysaccharide Tetanus Protein Conjugate - Group 6 Meningococcal polysaccharide group C conjugated - Group 1 Meningococcal Polysaccharide Tetanus Protein Conjugate - Group 3 Meningococcal Polysaccharide Tetanus Protein Conjugate -
- Primary Outcome Measures
Name Time Method To provide information concerning the safety and immunogenicity after administration of TetraMenT 30 days after each injection
- Secondary Outcome Measures
Name Time Method