NCT00258856

Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®

Persistence of Bactericidal Antibodies in Children Aged 7 to 15 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 7 Years – 15 Years
• Healthy volunteers: Accepted

Summary

The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.

Conditions

• Meningitis
• Meningococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	Polysaccharide Diphtheria Conjugate Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Polysaccharide Diphtheria Conjugate Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Polysaccharide Diphtheria Conjugate Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Polysaccharide Diphtheria Conjugate Vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-03-01
• Completion: 2007-11-01
• First posted: 2005-11-28
• Last updated: 2014-02-14
• Results posted: 2009-11-25

Locations

11 sites across 1 country: United States