NCT00631995

Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers

Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in Toddlers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Meningitis
• Meningococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide Tetanus Protein Conjugate	0.5 mL, Intramuscular
BIOLOGICAL	Meningococcal Polysaccharide Tetanus Protein Conjugate	0.5 mL, Intramuscular
BIOLOGICAL	Meningococcal Polysaccharide Tetanus Protein Conjugate	0.5 mL, Intramuscular
BIOLOGICAL	Meningococcal Polysaccharide Tetanus Protein Conjugate	0.5 mL, Intramuscular
BIOLOGICAL	Meningococcal Polysaccharide Tetanus Protein Conjugate	0.5 mL, Intramuscular
DIETARY_SUPPLEMENT	Meningococcal polysaccharide group C conjugated	0.5 mL, Intramuscular

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-02-01
• Completion: 2009-04-01
• First posted: 2008-03-10
• Last updated: 2018-02-06

Locations

5 sites across 1 country: Australia