NCT00700635

Dose Comparison Study of Menactra® in US Children

Exploratory Evaluation of a Two-dose Schedule Versus a One-dose Schedule of Menactra® (Meningococcal [Groups A, C, Y and W 135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) in Children in the US

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Accepted

Summary

To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children. Primary Objective: To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.

Detailed description

This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.

Conditions

• Meningitis
• Meningococcal Infection
• Neisseria Meningitidis

Interventions

Type	Name	Description
BIOLOGICAL	Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate	0.5 mL, 2 doses Intramuscular
BIOLOGICAL	Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate	0.5 mL, 2 doses Intramuscular
BIOLOGICAL	Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate	0.5 mL, 1 dose Intramuscular

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-05-01
• Completion: 2009-10-01
• First posted: 2008-06-19
• Last updated: 2016-04-14
• Results posted: 2010-12-23

Locations

15 sites across 1 country: United States