NCT00355121

Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

Immunogenicity and Safety of Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 882 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone. Safety: To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.

Conditions

• Meningococcal Meningitis
• Tetanus
• Diphtheria
• Pertussis
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Polysaccharide Diphtheria Toxoid Conjugate Vaccine	0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
BIOLOGICAL	Polysaccharide Diphtheria Toxoid Conjugate Vaccine	0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
BIOLOGICAL	Polysaccharide Diphtheria Toxoid Conjugate Vaccine	0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2006-07-21
• Last updated: 2011-08-24
• Results posted: 2011-08-23

Locations

26 sites across 1 country: United States