NCT01018732

A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vaccine or Menomune®.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 16 Years – 23 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Detailed description

Persistence of antibody response at 5 years after one dose of MenACWY or Menomune

Conditions

• Meningococcal Disease
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Novartis Meningococcal (MenACWY-CRM) vaccine	All subjects will have blood draws at Day 1, Day 8, and Day 29.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-11-25
• Last updated: 2015-07-15
• Results posted: 2011-09-13

Locations

3 sites across 1 country: United States