NCT00856297

Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine

An Open-Label, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Commercially Available MenACWY Conjugate Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 389 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. 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.

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM conjugate vaccine
BIOLOGICAL	Licensed comparator

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2009-03-05
• Last updated: 2017-06-14
• Results posted: 2014-01-22

Locations

32 sites across 1 country: United States